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Acetaminophen/Butalbital/Caffeine/Codeine

Pronunciation: a-SEET-a-MIN-oh-fen/bue-TAL-bi-tal/KAF-een/KOE-deen
Generic Name: Acetaminophen/Butalbital/Caffeine/Codeine
Brand Name: Examples include Fioricet with Codeine and Phrenilin with Caffeine and Codeine

Acetaminophen/Butalbital/Caffeine/Codeine contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Acetaminophen/Butalbital/Caffeine/Codeine is used for:

Relieving tension headaches. It may also be used for other conditions as determined by your doctor.

Acetaminophen/Butalbital/Caffeine/Codeine is a barbiturate, analgesic, stimulant, and narcotic combination. Acetaminophen and codeine work in the brain to relieve pain. Caffeine constricts blood vessels in the brain, which may help to relieve headache pain. Butalbital reduces anxiety and helps you to relax.

Do NOT use Acetaminophen/Butalbital/Caffeine/Codeine if:

you are allergic to any ingredient in Acetaminophen/Butalbital/Caffeine/Codeine

you have the blood disease porphyria

you have severe diarrhea caused by antibiotics or food poisoning

you are taking quinidine or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Butalbital/Caffeine/Codeine:

Some medical conditions may interact with Acetaminophen/Butalbital/Caffeine/Codeine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to an opioid pain medicine (eg, morphine)

if you have liver, kidney, or heart problems; an underactive thyroid; adrenal gland problems (eg, Addison disease); lung or breathing problems (eg, asthma); a blockage of your bowel or other stomach or bowel problem (eg, paralytic ileus); an enlarged prostate; bladder blockage; multiple, recurrent headaches; or trouble urinating

if you have a history of alcohol or other substance abuse or dependence, anxiety, depression, mental or mood problems, or suicidal thoughts or actions

if you have a head injury, increased pressure in the head, growths in the brain, or a history of seizures

if you are in very poor health, have trouble sleeping, or have had recent stomach or bowel surgery

Some MEDICINES MAY INTERACT with Acetaminophen/Butalbital/Caffeine/Codeine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of bleeding may be increased

Medicines that may harm the liver (eg, acetaminophen, certain medicines for HIV infection, isoniazid, ketoconazole, methotrexate) because the risk of liver side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the liver

Benzodiazepines (eg, chlordiazepoxide, temazepam), cimetidine, HIV protease inhibitors (eg, ritonavir), isoniazid, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), quinolone antibiotics (eg, ciprofloxacin), or sodium oxybate (GHB) because they may increase the risk of Acetaminophen/Butalbital/Caffeine/Codeine's side effects

Buprenorphine, naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease Acetaminophen/Butalbital/Caffeine/Codeine's effectiveness

Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, certain hormonal birth control, estradiol), griseofulvin, metronidazole, or tacrolimus because their effectiveness may be decreased by Acetaminophen/Butalbital/Caffeine/Codeine

Theophylline because its effectiveness may be decreased or the risk of its side effects may be increased by Acetaminophen/Butalbital/Caffeine/Codeine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Butalbital/Caffeine/Codeine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Butalbital/Caffeine/Codeine:

Use Acetaminophen/Butalbital/Caffeine/Codeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Acetaminophen/Butalbital/Caffeine/Codeine by mouth with or without food.

Do not take more than 6 capsules in 24 hours

If you miss a dose of Acetaminophen/Butalbital/Caffeine/Codeine and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are unsure what to do if you miss a dose. Do not take Acetaminophen/Butalbital/Caffeine/Codeine more often than prescribed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Butalbital/Caffeine/Codeine.

Important safety information:

Acetaminophen/Butalbital/Caffeine/Codeine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Butalbital/Caffeine/Codeine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, muscle relaxers, sleep aids) while you are using Acetaminophen/Butalbital/Caffeine/Codeine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Do NOT take more than the recommended dose or take for longer than prescribed without checking with your doctor. Doing so may be habit-forming.

Pain medications work best if they are used as the first signs of pain (or headache) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well.

Acetaminophen/Butalbital/Caffeine/Codeine has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Contact your doctor right away if you take more than 4,000 mg of acetaminophen per day, even if you feel well.

Acetaminophen/Butalbital/Caffeine/Codeine may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Butalbital/Caffeine/Codeine. Talk to your doctor before you take Acetaminophen/Butalbital/Caffeine/Codeine or other fever reducers if you drink more than 3 drinks with alcohol per day.

Tell your doctor or dentist that you take Acetaminophen/Butalbital/Caffeine/Codeine before you receive any medical or dental care, emergency care, or surgery.

Hormonal birth control (eg, birth control pills) may not work as well while you are using Acetaminophen/Butalbital/Caffeine/Codeine. To prevent pregnancy, use an extra form of birth control (eg, condoms).

Acetaminophen/Butalbital/Caffeine/Codeine may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Acetaminophen/Butalbital/Caffeine/Codeine.

Lab tests, including liver and kidney function, may be performed while you use Acetaminophen/Butalbital/Caffeine/Codeine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Acetaminophen/Butalbital/Caffeine/Codeine with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, excitement, or depression.

Acetaminophen/Butalbital/Caffeine/Codeine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is not known if Acetaminophen/Butalbital/Caffeine/Codeine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Butalbital/Caffeine/Codeine while you are pregnant. Using Acetaminophen/Butalbital/Caffeine/Codeine during labor may cause harm to the infant. Acetaminophen/Butalbital/Caffeine/Codeine is found in breast milk. Do not breast-feed while taking Acetaminophen/Butalbital/Caffeine/Codeine.

When used for long periods of time or at high doses, Acetaminophen/Butalbital/Caffeine/Codeine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Acetaminophen/Butalbital/Caffeine/Codeine stops working well. Do not take more than prescribed.

Some people who use Acetaminophen/Butalbital/Caffeine/Codeine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Acetaminophen/Butalbital/Caffeine/Codeine, you may experience WITHDRAWAL symptoms including anxiety; confusion; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; hallucinations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seizures; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Acetaminophen/Butalbital/Caffeine/Codeine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; intoxicated feeling; light-headedness; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); confusion; fainting; fast heartbeat; mental or mood changes; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe drowsiness; severe or persistent vomiting; shortness of breath; slow or shallow breathing; symptoms of liver problems (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, severe or persistent nausea or stomach pain).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Acetaminophen/Butalbital/Caffeine/Codeine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold or clammy skin; confusion; dark urine; decreased urination; delirium; excessive sweating; fast or irregular heartbeat; loss of consciousness; pinpoint pupils; restlessness; seizures; severe drowsiness or dizziness; severe or persistent nausea or vomiting; severe or persistent trouble sleeping; slow or shallow breathing; tremor; unusual bruising or bleeding; yellowing of the skin or eyes.

Proper storage of Acetaminophen/Butalbital/Caffeine/Codeine:

Store Acetaminophen/Butalbital/Caffeine/Codeine below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Butalbital/Caffeine/Codeine out of the reach of children and away from pets.

General information:

If you have any questions about Acetaminophen/Butalbital/Caffeine/Codeine, please talk with your doctor, pharmacist, or other health care provider.

Acetaminophen/Butalbital/Caffeine/Codeine is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen/Butalbital/Caffeine/Codeine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Acetaminophen/Butalbital/Caffeine/Codeine resources

Acetaminophen/Butalbital/Caffeine/Codeine Side Effects (in more detail)
Acetaminophen/Butalbital/Caffeine/Codeine Dosage
Acetaminophen/Butalbital/Caffeine/Codeine Use in Pregnancy & Breastfeeding
Drug Images
Acetaminophen/Butalbital/Caffeine/Codeine Drug Interactions
Acetaminophen/Butalbital/Caffeine/Codeine Support Group
8 Reviews for Acetaminophen/Butalbital/Caffeine/Codeine - Add your own review/rating

Compare Acetaminophen/Butalbital/Caffeine/Codeine with other medications

Headache

acetaminophen/chlorpheniramine/phenylephrine

Generic Name: acetaminophen, chlorpheniramine, and phenylephrine (a SEET a MIN oh fen, KLOR fen EER a meen, FEN ill EFF rin)

Brand names: Alka-Seltzer Plus Cold, Allergy Relief Multi-Symptom, Comtrex Flu Therapy, Comtrex Severe Cold & Sinus, Dristan Cold Multi Symptom Formula, Dryphen, Protid, Sinus Congestion & Pain Nighttime, Tylenol Allergy Multi-Symptom, Tylenol Children's Plus Cold, Tylenol Sinus Congestion Nighttime, ...show all 17 brand names.

What is acetaminophen, chlorpheniramine, and phenylephrine?

Acetaminophen is a pain reliever and fever reducer.

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acetaminophen, chlorpheniramine, and phenylephrine is used to treat runny or stuffy nose, sinus congestion, sneezing, and pain or fever caused by allergies or the common cold.

Acetaminophen, chlorpheniramine, and phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen, chlorpheniramine, and phenylephrine?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as "APAP"), chlorpheniramine, or phenylephrine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day.

What should I discuss with my healthcare provider before taking acetaminophen, chlorpheniramine, and phenylephrine?

Do not use this medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a decongestant before the MAO inhibitor has cleared from your body. Do not take this medication if you are allergic to acetaminophen, chlorpheniramine, or phenylephrine, or to other antihistamines or decongestants, diet pills, stimulants, or ADHD medications.

Ask a doctor or pharmacist about using acetaminophen, chlorpheniramine, and phenylephrine if you have:

heart disease or high blood pressure;

liver disease, alcoholism, or cirrhosis of the liver;

glaucoma;

kidney disease;

diabetes;

a thyroid disorder;

an enlarged prostate; or

problems with urination.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take acetaminophen, chlorpheniramine, and phenylephrine?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine should be taken only for a short time until your symptoms clear up.

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen, chlorpheniramine, and phenylephrine tablet may contain up to 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Always ask a doctor before giving cough or cold medicine to a child. Death can occur from the misuse of cough or cold medicine in very young children. Take this medication with food or milk if it upsets your stomach. Drink extra fluids while you are taking acetaminophen, chlorpheniramine, and phenylephrine.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store this medication at room temperature, away from heat, light, and moisture.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include feeling restless or nervous, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking acetaminophen, chlorpheniramine, and phenylephrine?

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other cough, cold, allergy, or pain medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP"), chlorpheniramine, and phenylephrine are contained in many cold and pain medicines available over the counter. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, chlorpheniramine, or phenylephrine. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather.

Acetaminophen, chlorpheniramine, and phenylephrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeat;

confusion, hallucinations, unusual thoughts or behavior;

severe dizziness, anxiety, restless feeling, or nervousness;

increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

urinating less than usual or not at all;

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

blurred vision;

dry mouth;

mild loss of appetite;

nausea, stomach pain, constipation;

dizziness, drowsiness;

problems with memory or concentration;

ringing in your ears;

restless or excitability (especially in children);

sleep problems (insomnia);

skin rash, redness, or itching; or

warmth, tingling, or redness under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Acetaminophen/chlorpheniramine/phenylephrine Dosing Information

Usual Adult Dose for Cold Symptoms:

acetaminophen/chlorpheniramine/phenylephrine varying strength oral kit:
Day time tablets (without chlorpheniramine): 2 tablets every 4 hours not to exceed 8 tablets daily.
Night time tablets: 2 tablets every 4 hours no sooner than 4 hours after the last day time dose not to exceed 4 tablets daily.

Usual Adult Dose for Sinus Symptoms:

Usual Pediatric Dose for Cold Symptoms:

acetaminophen/chlorpheniramine/phenylephrine varying strength oral kit:
12 years or older: Day time tablets (without chlorpheniramine): 2 tablets every 4 hours not to exceed 8 tablets daily. Night time tablets: 2 tablets every 4 hours no sooner than 4 hours after the last day time dose not to exceed 4 tablets daily.

acetaminophen/chlorpheniramine/phenylephrine 160 mg-1 mg-2.5 mg/5 mL oral liquid:
6 to 11 years or 22 to 43 kg: 10 mL orally every 4 hours not to exceed 5 doses.

Usual Pediatric Dose for Sinus Symptoms:

What other drugs will affect acetaminophen, chlorpheniramine, and phenylephrine?

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

Also tell your doctor if you are using any of the following drugs:

an antidepressant;

a bronchodilator;

a diuretic (water pill);

gout medications;

blood pressure medication;

medication to treat irritable bowel syndrome;

bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

seizure medication;

isoniazid;

zidovudine (Retrovir, AZT);

aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others); or

a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen, chlorpheniramine, and phenylephrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More acetaminophen/chlorpheniramine/phenylephrine resources

Acetaminophen/chlorpheniramine/phenylephrine Side Effects (in more detail)
Acetaminophen/chlorpheniramine/phenylephrine Use in Pregnancy & Breastfeeding
Acetaminophen/chlorpheniramine/phenylephrine Drug Interactions
Acetaminophen/chlorpheniramine/phenylephrine Support Group
3 Reviews for Acetaminophen/chlorpheniramine/phenylephrine - Add your own review/rating

Compare acetaminophen/chlorpheniramine/phenylephrine with other medications

Cold Symptoms
Sinus Symptoms

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, chlorpheniramine, and phenylephrine.

See also: acetaminophen/chlorpheniramine/phenylephrine side effects (in more detail)

Acetaminophen/Caffeine/Isometheptene

Pronunciation: a-SEET-a-MIN-oh-fen/EYE-soe-meth-EPP-teen/KAF-een
Generic Name: Acetaminophen/Isometheptene/Caffeine
Brand Name: Examples include Migralam and Proctrin

Acetaminophen/Caffeine/Isometheptene contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Acetaminophen/Caffeine/Isometheptene is used for:

Treating certain types of headaches (tension, vascular). It may also be used to treat migraine headaches or for other conditions as determined by your doctor.

Acetaminophen/Caffeine/Isometheptene is a combination analgesic, xanthene derivative, and sympathomimetic. It works by decreasing pain and narrowing the blood vessels in the head and brain.

Do NOT use Acetaminophen/Caffeine/Isometheptene if:

you are allergic to any ingredient in Acetaminophen/Caffeine/Isometheptene

you have glaucoma, severe kidney problems, high blood pressure, heart problems, or liver problems

you are taking droxidopa or have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Caffeine/Isometheptene:

Some medical conditions may interact with Acetaminophen/Caffeine/Isometheptene. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have alcoholism or if you consume 3 or more alcohol-containing drinks every day

if you have liver or kidney problems, hepatitis, high blood pressure, heart problems, blood vessel problems, or the blood disease porphyria

if you have had a recent heart attack

if you have anxiety or trouble sleeping

Some MEDICINES MAY INTERACT with Acetaminophen/Caffeine/Isometheptene. Tell your health care provider if you are taking any other medicines, especially any of the following:

Catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), quinolones (eg, ciprofloxacin), or tricyclic antidepressants (eg, amitriptyline) because the side effects of Acetaminophen/Caffeine/Isometheptene may be increased

Droxidopa because the risk of severe heart problems, including irregular heartbeat or heart attack, may be increased

Furazolidone or MAOIs (eg, phenelzine) because the risk of severe side effects, such as severe headache, high blood pressure, or high fever, may be increased

Isoniazid or other medicines that may harm the liver (eg, methotrexate, ketoconazole) because the risk of side effects on the liver may be increased. Talk with your doctor if you are unsure if any of your medicines may harm the liver.

Anticoagulants (eg, warfarin), bromocriptine, or theophylline because the side effects may be increased by Acetaminophen/Caffeine/Isometheptene

Guanadrel or guanethidine because their effectiveness may be decreased by Acetaminophen/Caffeine/Isometheptene

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Caffeine/Isometheptene may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Caffeine/Isometheptene:

Use Acetaminophen/Caffeine/Isometheptene as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Acetaminophen/Caffeine/Isometheptene may be taken with or without food.

For a migraine headache - Take Acetaminophen/Caffeine/Isometheptene at the first sign of a headache. If the initial dose does not relieve your headache, additional doses may be needed according to your doctor's instructions. Do not take a dose of Acetaminophen/Caffeine/Isometheptene within 60 minutes of your last dose. Do not take more than 5 capsules or tablets within a 12-hour period.

For a tension headache - Do not take more than 8 capsules or tablets within a 24-hour period.

If you miss a dose of Acetaminophen/Caffeine/Isometheptene and you still have a headache, take it as soon as you remember. If you need to take additional doses, continue to follow your doctor's dosing instructions. Do not take Acetaminophen/Caffeine/Isometheptene more often than directed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Caffeine/Isometheptene.

Important safety information:

Acetaminophen/Caffeine/Isometheptene may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Caffeine/Isometheptene with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Acetaminophen/Caffeine/Isometheptene contains acetaminophen. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see if it also contains acetaminophen. If it does or if you are uncertain, contact your doctor or pharmacist.

If you consume 3 or more alcohol-containing drinks every day, ask your doctor whether you should take Acetaminophen/Caffeine/Isometheptene or other pain relievers/fever reducers. Acetaminophen may cause liver damage. Alcohol use combined with Acetaminophen/Caffeine/Isometheptene may increase your risk for liver damage.

Use Acetaminophen/Caffeine/Isometheptene with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Acetaminophen/Caffeine/Isometheptene during pregnancy. Acetaminophen/Caffeine/Isometheptene is found in breast milk. If you are or will be breast-feeding while you are using Acetaminophen/Caffeine/Isometheptene, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Acetaminophen/Caffeine/Isometheptene:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Temporary dizziness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; right-sided abdominal pain or tenderness; unusual fatigue; yellowing of the skin or eyes.

See also: Acetaminophen/Caffeine/Isometheptene side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bloody vomit; dark urine; excessive sweating; extreme fatigue; irregular heartbeat; nausea and vomiting; stomach pain.

Proper storage of Acetaminophen/Caffeine/Isometheptene:

Store Acetaminophen/Caffeine/Isometheptene at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Caffeine/Isometheptene out of the reach of children and away from pets.

General information:

If you have any questions about Acetaminophen/Caffeine/Isometheptene, please talk with your doctor, pharmacist, or other health care provider.

Acetaminophen/Caffeine/Isometheptene is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen/Caffeine/Isometheptene. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Acetaminophen/Caffeine/Isometheptene resources

Acetaminophen/Caffeine/Isometheptene Side Effects (in more detail)
Acetaminophen/Caffeine/Isometheptene Use in Pregnancy & Breastfeeding
Acetaminophen/Caffeine/Isometheptene Drug Interactions
Acetaminophen/Caffeine/Isometheptene Support Group
6 Reviews for Acetaminophen/Caffeine/Isometheptene - Add your own review/rating

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Headache

acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine

Generic Name: acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine (a seet a MIN oh fen/klor fen IR a meen/dex troe meth OR fan/fen ill proe pa NOLE a meen)

Brand Names: Comtrex Cold and Flu Maximum Strength, Comtrex Maximum Strength Cold Relief, Contac Severe Cold and Flu Maximum Stength

What is acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Acetaminophen is a pain reliever and a fever reducer. It is used to treat many conditions, such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers.

Chlorpheniramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body. Chlorpheniramine prevents sneezing; itchy, watery eyes and nose; and other symptoms of allergies and hay fever.

Dextromethorphan is a cough suppressant. It suppresses an area in the brain that causes coughing.

Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries) allowing nasal passages to open up.

Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is used to treat nasal congestion, sinusitis (inflammation of the sinuses), runny nose, watery eyes, headache, body aches, and coughs associated with allergies, hay fever, and the common cold.

Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.

Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Use caution when driving, operating machinery, or performing other hazardous activities. Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine. Alcohol may also cause damage to the liver when it is taken with acetaminophen.

Who should not take acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Do not take this medication without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease. You may not be able to take acetaminophen.

Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

kidney disease,

liver disease,

diabetes,

glaucoma,

any type of heart disease or high blood pressure,

thyroid disease,

emphysema or chronic bronchitis, or

difficulty urinating or an enlarged prostate.

You may not be able to take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine will harm an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant. This medication passes into breast milk and may harm a nursing infant. Do not take this medication without first talking to your doctor if you are breast-feeding a baby. Read the package label for directions or consult your doctor or pharmacist before treating a child with this medication. Children are more susceptible than adults to the effects of medicines and may have unusual reactions. If you are over 60 years of age, you may be more likely to experience side effects from acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine.

How should I take acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine exactly as directed. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Do not take more of this medication than is recommended. An overdose of this medication can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage the liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never take more than 2 grams (2000 mg) per day.

Do not take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine for longer than 7 days in a row. If your symptoms do not improve, if they get worse, or if you have a fever, see your doctor.

Store acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine overdose include a dry mouth, large pupils, flushing, sweating, nausea, vomiting, diarrhea, abdominal pain, seizures, confusion, an irregular heartbeat, hyperactivity, or hallucinations.

What should I avoid while taking acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, other antihistamines, pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Dangerous sedation, dizziness, or drowsiness may occur if acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is taken with any of these medications.

Acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine side effects

If you experience any of the following rare but serious side effects, stop taking acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine and seek emergency medical attention or notify your doctor immediately:

an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, or severe fatigue);

blood problems (easy or unusual bleeding or bruising); or

low blood sugar (fatigue, increased hunger or thirst, dizziness, or fainting).

Other, less serious side effects may be more likely to occur. Continue to take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine and talk to your doctor or try another similar medication if you experience

dryness of the eyes, nose, and mouth;

drowsiness or dizziness;

blurred vision;

difficulty urinating; or

excitation in children.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine?

Do not take acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Urine glucose tests may produce false results while you are taking acetaminophen. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.

Do not take other over-the-counter cough, cold, allergy, diet, pain, or sleep medicines while taking acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain chlorpheniramine, phenylpropanolamine, acetaminophen, or other similar drugs, and you may accidentally take too much of these medicines.

Drugs other than those listed here may also interact with acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

More acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine resources

Acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine Drug Interactions
Acetaminophen/ chlorpheniramine/ dextromethorphan/ phenylpropanolamine Support Group
0 Reviews · Be the first to review/rate this drug

Where can I get more information?

Your pharmacist has additional information about acetaminophen/chlorpheniramine/ dextromethorphan/phenylpropanolamine written for health professionals that you may read.

What does my medication look like?

Acetaminophen/chlorpheniramine/dextromethorphan/phenylpropanolamine is available over the counter under the brand name Comtrex. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

acetaminophen, butalbital, and caffeine

Generic Name: acetaminophen, butalbital, and caffeine (a SEET a MIN oh fen, bue TAL bi tal, and KAF een)

Brand names: Alagesic, Anolor 300, Dolgic LQ, Dolgic Plus, Esgic, Esgic-Plus, Fioricet, Geone, Margesic, Medigesic, Repan, Zebutal, ...show all 34 brand names.

What is acetaminophen, butalbital, and caffeine?

Acetaminophen is a pain reliever and fever reducer.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

The combination of acetaminophen, butalbital, and caffeine is used to treat tension headaches that are caused by muscle contractions.

Acetaminophen, butalbital, and caffeine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen, butalbital, and caffeine?

Do not use acetaminophen, butalbital, and caffeine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Tell your doctor if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

What should I discuss with my healthcare provider before taking acetaminophen, butalbital, and caffeine?

To make sure you can safely take acetaminophen, butalbital, and caffeine, tell your doctor if you have any of these other conditions:

kidney disease,

liver disease; or

a history of mental illness or suicidal thoughts.

Butalbital may be habit forming and should be used only by the person it was prescribed for. Never share this medication with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. FDA pregnancy category C. It is not known whether acetaminophen, butalbital, and caffeine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen, butalbital, and caffeine?

Take exactly as prescribed. Never take acetaminophen, butalbital, and caffeine in larger amounts, or for longer than recommended by your doctor. An overdose of this medication can damage your liver or cause death.Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Take the medicine with food or milk if it upsets your stomach. Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Butalbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

See also: Acetaminophen, butalbital, and caffeine dosage (in more detail)

What happens if I miss a dose?

Since this medication is usually taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may also include insomnia, restlessness, tremor, dizziness, drowsiness, diarrhea, increased sweating, shallow breathing, confusion, uneven heartbeats, seizure (convulsions), or coma.

What should I avoid while taking acetaminophen, butalbital, and caffeine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

While you are taking this medication, avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice.

Acetaminophen, butalbital, and caffeine side effects

fast, pounding, or uneven heartbeat;

feeling light-headed or short of breath;

nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms.

Less serious side effects may include:

drowsiness;

dizziness, confusion or lightheadedness;

dry mouth;

nausea, vomiting, stomach pain, loss of appetite;

feeling anxious or jittery;

drunk feeling; or

headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Acetaminophen, butalbital, and caffeine Dosing Information

Usual Adult Dose for Headache:

Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

Acetaminophen 325 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 tablet(s), capsule(s), or tablespoonful(s) orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 500 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet or capsule orally every 4 hours.
Maximum daily dose: 6 doses

Acetaminophen 750 mg, butalbital 50 mg, and caffeine 40 mg:
1 tablet orally every 4 hours.
Maximum daily dose: 5 tablets

Usual Pediatric Dose for Headache:

12 years and older:
Acetaminophen 300 mg, butalbital 50 mg, and caffeine 40 mg:
1 or 2 capsule(s) orally every 4 hours as needed. Maximum daily dose: 6 doses.

What other drugs will affect acetaminophen, butalbital, and caffeine?

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by butalbital.

Tell your doctor about all other medicines you use, especially:

an antibiotic;

a blood thinner such as warfarin (Coumadin, Jantoven);

isoniazid (for treating tuberculosis);

zidovudine (Retrovir, AZT);

seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);

gout medications such as probenecid (Benemid) or sulfinpyrazone;

steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or

an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

This list is not complete and other drugs may interact with acetaminophen, butalbital, and caffeine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More acetaminophen, butalbital, and caffeine resources

Acetaminophen, butalbital, and caffeine Side Effects (in more detail)
Acetaminophen, butalbital, and caffeine Dosage
Acetaminophen, butalbital, and caffeine Use in Pregnancy & Breastfeeding
Drug Images
Acetaminophen, butalbital, and caffeine Drug Interactions
Acetaminophen, butalbital, and caffeine Support Group
80 Reviews for Acetaminophen, butalbital, and caffeine - Add your own review/rating

Compare acetaminophen, butalbital, and caffeine with other medications

Headache

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, butalbital, and caffeine.

See also: acetaminophen, butalbital, and caffeine side effects (in more detail)

Acetaminophen/Butalbital/Caffeine Elixir

Pronunciation: ah-seet-ah-MIN-oh-fen/byoo-TAL-bi-tal/kaf-EEN
Generic Name: Acetaminophen/Butalbital/Caffeine
Brand Name: Examples include Alagesic LQ and Dolgic LQ

Acetaminophen/Butalbital/Caffeine Elixir contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Acetaminophen/Butalbital/Caffeine Elixir is used for:

Relieving tension headaches. It may also be used for other conditions as determined by your doctor.

How these medicines work is not completely understood. Acetaminophen works in the brain to relieve pain. Caffeine may work by constricting blood vessels that may cause headaches. Butalbital has a depressant effect that reduces anxiety and causes relaxation.

Do NOT use Acetaminophen/Butalbital/Caffeine Elixir if:

you are allergic to any ingredient in Acetaminophen/Butalbital/Caffeine Elixir

you have the blood disease porphyria

you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Butalbital/Caffeine Elixir:

Some medical conditions may interact with Acetaminophen/Butalbital/Caffeine Elixir. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have liver problems, severe kidney problems, severe heart disease, a lung or respiratory tract disease, or difficulty sleeping

if you have a history of substance abuse or dependence, anxiety, depression, or suicidal thoughts or behaviors

Some MEDICINES MAY INTERACT with Acetaminophen/Butalbital/Caffeine Elixir. Tell your health care provider if you are taking any other medicines, especially any of the following:

Benzodiazepines (eg, chlordiazepoxide), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), sleeping medicines (eg, temazepam), or sodium oxybate (GHB) because they may increase the risk of Acetaminophen/Butalbital/Caffeine Elixir's side effects

Anticoagulants (eg, warfarin) or isoniazid because the risk of side effects, including bleeding and liver problems, may be increased

Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, estradiol, oral contraceptives), metronidazole, quinidine, quinolone antibiotics (eg, ciprofloxacin), or theophylline, because their effectiveness may be decreased by Acetaminophen/Butalbital/Caffeine Elixir

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Butalbital/Caffeine Elixir may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Butalbital/Caffeine Elixir:

Use Acetaminophen/Butalbital/Caffeine Elixir as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Acetaminophen/Butalbital/Caffeine Elixir by mouth with or without food.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

If you miss a dose of Acetaminophen/Butalbital/Caffeine Elixir and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is almost time for your next dose, do not double the dose to catch up, unless advised to do so by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Butalbital/Caffeine Elixir.

Important safety information:

Acetaminophen/Butalbital/Caffeine Elixir may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Butalbital/Caffeine Elixir with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Butalbital/Caffeine Elixir; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

Pain medications work best if they are used as the first signs of pain (or migraine) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well.

Acetaminophen/Butalbital/Caffeine Elixir has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Acetaminophen/Butalbital/Caffeine Elixir may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Butalbital/Caffeine Elixir. Talk to your doctor before you take Acetaminophen/Butalbital/Caffeine Elixir or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day.

Tell your doctor or dentist that you take Acetaminophen/Butalbital/Caffeine Elixir before you receive any medical or dental care, emergency care, or surgery.

Hormonal birth control (eg, birth control pills) may not work as well while you are using Acetaminophen/Butalbital/Caffeine Elixir. To prevent pregnancy, use an extra form of birth control (eg, condoms).

Lab tests, including liver and kidney function, may be performed while you use Acetaminophen/Butalbital/Caffeine Elixir. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Acetaminophen/Butalbital/Caffeine Elixir with caution in the ELDERLY; they may be more sensitive to its effects.

Acetaminophen/Butalbital/Caffeine Elixir should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Butalbital/Caffeine Elixir while you are pregnant. Acetaminophen/Butalbital/Caffeine Elixir is found in breast milk. Do not breast-feed while taking Acetaminophen/Butalbital/Caffeine Elixir.

When used for long periods of time or at high doses, Acetaminophen/Butalbital/Caffeine Elixir may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Acetaminophen/Butalbital/Caffeine Elixir stops working well. Do not take more than prescribed.

Some people who use Acetaminophen/Butalbital/Caffeine Elixir for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Acetaminophen/Butalbital/Caffeine Elixir suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures.

Possible side effects of Acetaminophen/Butalbital/Caffeine Elixir:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; intoxicated feeling; lightheadedness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; seizures; severe drowsiness; shortness of breath; slurred speech; stomach pain; weakness.

See also: Acetaminophen/Butalbital/Caffeine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold or clammy skin; confusion; dark urine; excessive sweating; extremely fast heartbeat; fatigue; lack of alertness; lightheadedness; loss of consciousness; nausea; sleeplessness; slow or shallow breathing; stomach pain; tremor; unusual drowsiness or dizziness; vomiting.

Proper storage of Acetaminophen/Butalbital/Caffeine Elixir:

Store Acetaminophen/Butalbital/Caffeine Elixir at room temperature between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Butalbital/Caffeine Elixir out of the reach of children and away from pets.

General information:

If you have any questions about Acetaminophen/Butalbital/Caffeine Elixir, please talk with your doctor, pharmacist, or other health care provider.

Acetaminophen/Butalbital/Caffeine Elixir is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen/Butalbital/Caffeine Elixir. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

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Headache

Acetaminophen/Butalbital/Caffeine

Pronunciation: ah-seet-ah-MIN-oh-fen/byoo-TAL-bi-tal/kaf-EEN
Generic Name: Acetaminophen/Butalbital/Caffeine
Brand Name: Examples include Dolgic Plus and Esgic-Plus

Acetaminophen/Butalbital/Caffeine contains acetaminophen. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor.

Acetaminophen/Butalbital/Caffeine is used for:

Relieving tension headaches. It may also be used for other conditions as determined by your doctor.

Do NOT use Acetaminophen/Butalbital/Caffeine if:

you are allergic to any ingredient in Acetaminophen/Butalbital/Caffeine

you have the blood disease porphyria

you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Butalbital/Caffeine:

Some medical conditions may interact with Acetaminophen/Butalbital/Caffeine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have liver problems, severe kidney problems, severe heart disease, a lung or respiratory tract disease, or difficulty sleeping

if you have a history of substance abuse or dependence, anxiety, depression, or suicidal thoughts or behaviors

Some MEDICINES MAY INTERACT with Acetaminophen/Butalbital/Caffeine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) or isoniazid because the risk of side effects, including bleeding and liver problems, may be increased

Benzodiazepines (eg, chlordiazepoxide), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), narcotic analgesics (eg, morphine), sleeping medicines (eg, temazepam), or sodium oxybate ( GHB) because they may increase the risk of Acetaminophen/Butalbital/Caffeine's side effects

Beta-blockers (eg, atenolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogens (eg, estradiol, oral contraceptives), metronidazole, quinidine, quinolone antibiotics (eg, ciprofloxacin), or theophylline, because their effectiveness may be decreased by Acetaminophen/Butalbital/Caffeine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Butalbital/Caffeine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Butalbital/Caffeine:

Use Acetaminophen/Butalbital/Caffeine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Acetaminophen/Butalbital/Caffeine by mouth with or without food.

If you miss a dose of Acetaminophen/Butalbital/Caffeine and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is almost time for your next dose, do not double the dose to catch up, unless advised to do so by your doctor. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Butalbital/Caffeine.

Important safety information:

Acetaminophen/Butalbital/Caffeine may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Butalbital/Caffeine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Butalbital/Caffeine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

Pain medications work best if they are used as the first signs of pain (or migraine) occur. If you wait until the pain has significantly worsened, the pain medicine may not work as well.

Acetaminophen/Butalbital/Caffeine has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Acetaminophen/Butalbital/Caffeine may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Butalbital/Caffeine. Talk to your doctor before you take Acetaminophen/Butalbital/Caffeine or other pain relievers/fever reducers if you drink more than 3 drinks with alcohol per day.

Tell your doctor or dentist that you take Acetaminophen/Butalbital/Caffeine before you receive any medical or dental care, emergency care, or surgery.

Hormonal birth control (eg, birth control pills) may not work as well while you are using Acetaminophen/Butalbital/Caffeine. To prevent pregnancy, use an extra form of birth control (eg, condoms).

Lab tests, including liver and kidney function, may be performed while you use Acetaminophen/Butalbital/Caffeine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Acetaminophen/Butalbital/Caffeine with caution in the ELDERLY; they may be more sensitive to its effects.

Acetaminophen/Butalbital/Caffeine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Butalbital/Caffeine while you are pregnant. Acetaminophen/Butalbital/Caffeine is found in breast milk. Do not breast-feed while taking Acetaminophen/Butalbital/Caffeine.

When used for long periods of time or at high doses, Acetaminophen/Butalbital/Caffeine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Acetaminophen/Butalbital/Caffeine stops working well. Do not take more than prescribed.

Some people who use Acetaminophen/Butalbital/Caffeine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Acetaminophen/Butalbital/Caffeine suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures.

Possible side effects of Acetaminophen/Butalbital/Caffeine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; intoxicated feeling; lightheadedness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; seizures; severe drowsiness; shortness of breath; slurred speech; stomach pain; weakness.

See also: Acetaminophen/Butalbital/Caffeine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold or clammy skin; confusion; dark urine; excessive sweating; extremely fast heartbeat; fatigue; lack of alertness; lightheadedness; loss of consciousness; nausea; sleeplessness; slow or shallow breathing; stomach pain; tremor; unusual drowsiness or dizziness; vomiting.

Proper storage of Acetaminophen/Butalbital/Caffeine:

Store Acetaminophen/Butalbital/Caffeine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Butalbital/Caffeine out of the reach of children and away from pets.

General information:

If you have any questions about Acetaminophen/Butalbital/Caffeine, please talk with your doctor, pharmacist, or other health care provider.

Acetaminophen/Butalbital/Caffeine is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen/Butalbital/Caffeine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Acetaminophen/Butalbital/Caffeine resources

Acetaminophen/Butalbital/Caffeine Side Effects (in more detail)
Acetaminophen/Butalbital/Caffeine Dosage
Acetaminophen/Butalbital/Caffeine Use in Pregnancy & Breastfeeding
Drug Images
Acetaminophen/Butalbital/Caffeine Drug Interactions
Acetaminophen/Butalbital/Caffeine Support Group
80 Reviews for Acetaminophen/Butalbital/Caffeine - Add your own review/rating

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