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acetaminophen, dextromethorphan, and pseudoephedrine

Generic Name: acetaminophen, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, DEX troe me THOR fan, SOO doe ee FED rin)

Brand names: Alka-Seltzer Plus Flu Liquigels, Comtrex Non-Drowsy, DayQuil, Dayquil Liquicaps, Daytime Cold, Non-Drowsy Daytime, Robitussin Honey Flu Non-Drowsy, Theraflu (pseudoephedrine) Daytime Severe Cold, Theraflu Severe Cold & Congestion Non-Drowsy, Triaminic Cough & Sore Throat (pseudoephedrine), Triaminic Softchew Throat Pain and Cough, Triaminic Softchews Cough & Sore Throat (pseudoephedrine), ...show all 41 brand names.

What is acetaminophen, dextromethorphan, and pseudoephedrine?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

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

The combination of acetaminophen, dextromethorphan, and pseudoephedrine is used to treat headache, fever, body aches, cough, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

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

What is the most important information I should know about acetaminophen, dextromethorphan, and pseudoephedrine?

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen. Do not use this medicine 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. 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.

What should I discuss with my healthcare provider before taking acetaminophen, dextromethorphan, and pseudoephedrine?

Do not take this medication without a doctor's advice 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 use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Do not use this medicine 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.

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, dextromethorphan, and pseudoephedrine if you have:

liver disease, cirrhosis, or a history of alcoholism;

diabetes;

glaucoma;

diabetes;

epilepsy or other seizure disorder;

enlarged prostate or urination problems;

pheochromocytoma (an adrenal gland tumor); or

cough with mucus, or cough caused by emphysema or chronic bronchitis.

It is not known whether acetaminophen, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take acetaminophen, dextromethorphan, and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not give this medication to a child younger than 4 years old. 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.

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

The chewable tablet must be chewed thoroughly before you swallow it.

Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.

Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.

What happens if I miss a dose?

Since this medicine is taken when 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. An overdose of acetaminophen can be fatal.

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 severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking acetaminophen, dextromethorphan, and pseudoephedrine?

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. This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen.

Acetaminophen, dextromethorphan, and pseudoephedrine 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. chest pain, fast, slow, or uneven heart rate; Stop using this medication and call your doctor at once if you have any of these serious side effects:

chest pain, fast, slow, or uneven heart rate;

severe dizziness, feeling like you might pass out;

mood changes, confusion, hallucinations;

tremor, seizure (convulsions);

fever;

urinating less than usual or not at all;

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

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

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

dizziness, weakness;

mild headache;

mild nausea, diarrhea, upset stomach;

dry mouth, nose, or throat;

feeling nervous, restless, irritable, or anxious; or

sleep problems (insomnia).

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, dextromethorphan, and pseudoephedrine Dosing Information

Usual Adult Dose for Cold Symptoms:

acetaminophen/dextromethorphan/pseudoephedrine 1000 mg-30 mg-60 mg /30 mL oral liquid:
30 mL orally every 6 hours not to exceed 4 doses daily.

acetaminophen/dextromethorphan/pseudoephedrine 325 mg-15 mg-30 mg oral capsule:
2 capsules orally with water every 6 hours not to exceed 8 capsules daily.

Usual Pediatric Dose for Cold Symptoms:

acetaminophen/dextromethorphan/pseudoephedrine 1000 mg-30 mg-60 mg /30 mL oral liquid:
12 yrs or older: 30 mL orally every 6 hours not to exceed 4 doses daily.

acetaminophen/dextromethorphan/pseudoephedrine 325 mg-15 mg-30 mg oral capsule:
12 yrs or older: 2 capsules with water every 6 hours not to exceed 8 capsules daily.

What other drugs will affect acetaminophen, dextromethorphan, and pseudoephedrine?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are also using any of the following drugs:

leflunomide (Arava);

tapentadol (Nucynta);

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

an antidepressant;

birth control pills or hormone replacement therapy;

blood pressure medication;

cancer medicine;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medication;

medicines to treat psychiatric disorders;

migraine headache medicine;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medication.

This list is not complete and other drugs may interact with acetaminophen, dextromethorphan, and pseudoephedrine. 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, dextromethorphan, and pseudoephedrine resources

Acetaminophen, dextromethorphan, and pseudoephedrine Side Effects (in more detail)
Acetaminophen, dextromethorphan, and pseudoephedrine Use in Pregnancy & Breastfeeding
Acetaminophen, dextromethorphan, and pseudoephedrine Drug Interactions
Acetaminophen, dextromethorphan, and pseudoephedrine Support Group
1 Review for Acetaminophen, dextromethorphan, and pseudoephedrine - Add your own review/rating

Compare acetaminophen, dextromethorphan, and pseudoephedrine with other medications

Cold Symptoms

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, dextromethorphan, and pseudoephedrine.

See also: acetaminophen, dextromethorphan, and pseudoephedrine side effects (in more detail)

Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets

Pronunciation: ah-seet-ah-MIN-oh-fen/klor-fen-EER-a-meen/fen-ill-EF-rin/fen-ill-tole-OX-a-meen
Generic Name: Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine
Brand Name: Norel SR

Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets are used for:

Relieving symptoms of colds, hay fever, and allergies such as headache, sinus pain, nasal and sinus congestion, sneezing, watery eyes, runny nose, fever, and itching of the nose or throat. It may also be used for other conditions as determined by your doctor.

Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets are an antihistamine, decongestant, and pain reliever combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion and pain associated with sinus pressure, and dries the nose and chest.

Do NOT use Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets if:

you are allergic to any ingredient in Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets

you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the last 14 days

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

Before using Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets:

Some medical conditions may interact with Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets. 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 a history of breathing problems (eg, emphysema, asthma), heart disease, diabetes, difficulty urinating, an enlarged prostate, glaucoma, high blood pressure, an overactive thyroid, liver or kidney problems, adrenal gland problems (eg, pheochromocytoma), sleep apnea, trouble sleeping, stomach problems, urinary blockage, increased eye pressure, or viral hepatitis

if you regularly drink large amounts of alcohol

Some MEDICINES MAY INTERACT with Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), droxidopa, isoniazid, furazolidone, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of side effects may be increased

Anticoagulants (eg, warfarin), bromocriptine, furazolidone, MAO inhibitors (eg, phenelzine), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because their actions and side effects may be increased by Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets

Certain high blood pressure medicines such as beta-blockers (eg, atenolol) and guanethidine because their effectiveness may be decreased by Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets 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/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets:

Use Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets may be taken with food if it upsets your stomach.

Swallow Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.

If you miss a dose of Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets.

Important safety information:

Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets. Using Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.

Do not exceed the recommended dose of Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets. Doing so will not improve your condition faster and may increase your risk for side effects.

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

Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets contains acetaminophen and phenylephrine. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains acetaminophen or phenylephrine. If it does or if you are uncertain, contact your doctor or pharmacist.

Do not take diet or appetite control medicines while you are taking Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets without checking with your doctor.

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

If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets.

Caution is advised when using Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets in the ELDERLY because they may be more sensitive to its effects.

Use Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.

PREGNANCY and BREAST-FEEDING: It is unknown if Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets can cause harm to the fetus. If you become pregnant while taking Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets, discuss with your doctor the benefits and risks of using Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets during pregnancy. Some of the ingredients in Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets are excreted in breast milk. If you are or will be breast-feeding while you are using Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets:

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; dry mouth, nose, or throat; headache; nausea; nervousness; trouble sleeping.

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); chest pain; dark urine or pale stools; difficulty urinating; hallucinations; high blood pressure; rapid pulse; severe nervousness; stomach pain; tremors; unusual fatigue; yellowing of the skin or eyes.

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/Chlorpheniramine/Phenylephrine/Phenyltoloxamine 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 fast or irregular heartbeat; fever; hallucinations; nausea; seizures; sweating; tremors; trouble breathing; unusual drowsiness or dizziness; vomiting.

Proper storage of Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets:

Store Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets are 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/Chlorpheniramine/Phenylephrine/Phenyltoloxamine Sustained-Release Tablets. 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/Chlorpheniramine/Phenylephrine/Phenyltoloxamine resources

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

Compare Acetaminophen/Chlorpheniramine/Phenylephrine/Phenyltoloxamine with other medications

Nasal Congestion

Acetaminophen Aspirin Codeine

Dosage Form: Capsules

Acetaminophen Aspirin Codeine Description

Acetaminophen, aspirin, and codeine phosphate capsules are available in three different strengths and colors:

                         150 mg/180 mg/15 mg          150 mg/180 mg/30 mg          150 mg/180 mg/60 mg

                                (grey / green)                            (grey / black)                              (grey / red)

Acetaminophen           150 mg                                   150 mg                                    150 mg

Aspirin                        180 mg                                   180 mg                                    180 mg

Codeine* Phosphate    15 mg                                     30 mg                                       60 mg

(*WARNING: May be habit forming)

Also contains pregelatinized starch and sodium lauryl sulfate with capsule shells composed of gelatin (containing silicon dioxide and sodium lauryl sulfate as manufacturing aides to the gelatin) with black iron oxide and titanium dioxide as color additives. In addition, the capsule containing 15 mg of codeine phosphate also contains: D&C Yellow #10, FD&C Blue #1 and FD&C Red #40. The capsule containing 60 mg codeine phosphate also contains: FD&C Blue #1 and FD&C Red #40.

Acetaminophen, 4′-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. Its structure is as follows:

C8H9NO2 M.W. 151.16

Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor, Its structure is as follows:

C9H8O4 MW. 180.16

Codeine is an alkaloid, obtained from opium or prepared from morphine by methylation. Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is: 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate. Its structure is as follows:

C18H21NO3•H3PO4•1/2 H2O M.W. 406.37

Acetaminophen Aspirin Codeine - Clinical Pharmacology

Acetaminophen, aspirin, and codeine phosphate capsules combine the analgesic effects of a centrally acting analgesic, codeine, with the peripherally acting analgesics, acetaminophen and aspirin. All ingredients are well absorbed orally. The plasma elimination half-life ranges from 1 to 4 hours for acetaminophen, and from 2.5 to 3 hours for codeine. Although aspirin has a half-life of only about 15 minutes, the apparent biologic half-life of salicylic acid in the therapeutic plasma concentration range is between 6 and 12 hours.

Codeine retains at least one-half of its analgesic activity when administered orally. A reduced first-pass metabolism of codeine by the liver accounts for the greater oral efficacy of codeine when compared to most other morphine-like narcotics. Following absorption, codeine is metabolized by the liver and metabolic products are excreted in the urine. Approximately 10 percent of the administered codeine is demethylated to morphine, which may account for its analgesic activity.

Acetaminophen is distributed throughout most fluids of the body, and is metabolized primarily in the liver. Little unchanged drug is excreted in the urine, but most metabolic products appear in the urine within 24 hours.

Aspirin is rapidly absorbed and almost totally hydrolyzed to salicylic acid following oral administration. Salicylic acid is eliminated by renal excretion and by biotransformation to inactive metabolites. Clearance of salicylic acid in the high-dose range is sensitive to urinary pH and is reduced by renal dysfunction.

Indications and Usage for Acetaminophen Aspirin Codeine

Acetaminophen, aspirin, and codeine phosphate capsules are indicated for the relief of mild to moderately severe pain.

Contraindications

Acetaminophen, aspirin, and codeine phosphate preparations should not be administered to patients who have previously exhibited hypersensitivity to any component. Aspirin containing products are contraindicated in patients with bleeding disorders.

Precautions

General

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions: The administration of this product or other narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Special Risk Patients: This drug should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, and prostatic hypertrophy or urethral stricture. Salicylates should be used with caution in patients with gastritis, peptic ulceration or coagulation abnormalities.

Information for Patients

Codeine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using this drug should be cautioned accordingly.

Caution patients with a predisposition for gastrointestinal bleeding that concomitant use of aspirin and alcohol may have an additive effect in this regard.

Drug Interactions

Patients receiving other narcotic analgesics, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with this drug may exhibit an additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

The concurrent use of anticholinergics with codeine may produce paralytic ileus.

Salicylates may enhance the effect of anticoagulants and inhibit the uricosuric effect of uricosuric agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term studies in animals have been performed with acetaminophen or codeine to determine carcinogenic potential or effects on fertility.

Acetaminophen and codeine have been found to have no mutagenic potential using the Ames Salmonella-Microsomal Activation test, the Basc test on Drosophila germ cells, and the Micronucleus test on mouse bone marrow.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Codeine: A study in rats and rabbits reported no teratogenic effect of codeine administered during the period of organogenesis in doses ranging from 5 to 120 mg/kg. In the rat, doses at the 120 mg/kg level, in the toxic range for the adult animal, were associated with an increase in embryo resorption at the time of implantation. In another study a single 100 mg/kg dose of codeine administered to pregnant mice reportedly resulted in delayed ossification in the offspring.

There are no studies in humans, and the significance of these findings to humans, if any, is not known.

Studies in rodents have shown salicylates to be teratogenic when given in early gestation, and embryocidal when given in later gestation in doses considerably greater than usual therapeutic doses in humans. Studies in women who took aspirin during pregnancy have not demonstrated an increased incidence of congenital abnormalities in the offspring.

This combination product should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Dependence has been reported in newborns whose mothers took opiates regularly during pregnancy. Withdrawal signs include irritability, excessive crying, tremors, hyperreflexia, fever, vomiting, and diarrhea. These signs usually appear during the first few days of life.

Labor and Delivery

Narcotic analgesics cross the placental barrier. The closer to delivery and the larger the dose used, the greater the possibility of respiratory depression in the newborn. Narcotic analgesics should be avoided during labor if delivery of a premature infant is anticipated. If the mother has received narcotic analgesics during labor, newborn infants should be observed closely for signs of respiratory depression. Resuscitation may be required (see OVERDOSAGE). The effect of codeine, it any, on the later growth, development, and functional maturation of the child is unknown.

Ingestion of aspirin near term or prior to delivery may prolong delivery or lead to bleeding in mother, fetus or neonate.

Nursing Mothers

Some studies, but not others, have reported detectable amounts of codeine in breast milk. The levels are probably not clinically significant after usual therapeutic dosage. The possibility of clinically important amounts being excreted in breast milk in individuals abusing codeine should be considered.

Aspirin is excreted in human milk in moderate amounts and can produce a bleeding tendency in nursing infants. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

Adverse Reactions

The most frequently observed adverse reactions include lightheadedness, dizziness, sedation, shortness of breath, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include allergic reactions, euphoria, dysphoria, constipation, abdominal pain and pruritus.

At higher doses codeine has most of the disadvantages of morphine including respiratory depression.

The most common adverse reactions associated with the use of aspirin have been gastrointestinal, including nausea, vomiting, gastritis, occult bleeding, constipation and diarrhea. Gastric erosion, angioedema, asthma, rash, pruritus and urticaria have been reported less commonly. Tinnitus is a sign of high serum salicylate levels (see OVERDOSAGE).

Aspirin Intolerance: Allergic type reactions in aspirin-sensitive individuals may involve the respiratory tract or the skin. Symptoms of the former range from rhinorrhea and shortness of breath to severe asthma, and the latter may consist of urticaria, edema, rash or angioedema (giant hives). These may occur independently or in combination.

Drug Abuse and Dependence

Acetaminophen, aspirin, and codeine phosphate capsules are a Schedule III controlled substance.

Codeine can produce drug dependence of the morphine type, and therefore has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of this drug, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic-containing medications.

Overdosage

Acetaminophen

Signs and Symptoms: In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur.

In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose.

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion.

Treatment: The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. Patients’ estimates of the quantity of drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals.

The antidote, N-acetylcysteine, should be administered as early as possible, preferably within 16 hours of the overdose ingestion for optimal results, but in any case, within 24 hours. Following recovery, there are no residual, structural or functional hepatic abnormalities.

Aspirin

Signs and Symptoms: Headache, tinnitus, hearing difficulty, dim vision, dizziness, lassitude, hyperpnea, rapid breathing, thirst, nausea, vomiting, sweating and occasionally diarrhea are characteristic of mild to moderate salicylate poisoning. Salicylate poisoning should be considered in children with symptoms of vomiting, hyperpnea, and hyperthermia.

Hyperpnea is an early sign of salicylate poisoning, but dyspnea supervenes at plasma levels above 50 mg/dL. These respiratory changes eventually lead to serious acid-base disturbances. Metabolic acidosis is a constant finding in infants but occurs in older children only with severe poisoning; adults usually exhibit respiratory alkalosis initially and acidosis terminally.

Other symptoms of severe salicylate poisoning include hyperthermia, dehydration, delirium, and mental disturbances. Skin eruptions, GI hemorrhage, or pulmonary edema are less common. Early CNS stimulation is replaced by increasing depression, stupor, and coma. Death is usually due to respiratory failure or cardiovascular collapse.

Treatment: Since there are no specific antidotes for salicylate poisoning, the aim of treatment is to enhance elimination of salicylate and prevent or reduce further absorption; to correct any fluid electrolyte or metabolic imbalance; and to provide general and cardiorespiratory support. If acidosis is present, intravenous sodium bicarbonate must be given, along with adequate hydration, until salicylate levels decrease to within the therapeutic range. To enhance elimination, forced diuresis and alkalinization of the urine may be beneficial. The need for hemoperfusion or hemodialysis is rare and should be used only when other measures have tailed.

Codeine

Signs andSymptoms: Serious overdose with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The narcotic antagonist naloxone is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to narcotics, including codeine. Therefore, an appropriate dose of naloxone hydrochloride (see package insert) should be administered, preferably by the intravenous route, and simultaneously with efforts at respiratory resuscitation. Since the duration of action of codeine may exceed that of the antagonist, the patient should be kept under continued surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration.

An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.

Gastric emptying may be useful in removing unabsorbed drug.

Acetaminophen Aspirin Codeine Dosage and Administration

Dosage should be adjusted according to severity of pain and response of the patient. It should be kept in mind, however, that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciably increased incidence of undesirable side effects. Equivalently high doses in children would have similar effects.

The dose of this combination product is limited by the amount of codeine phosphate per capsule. For adults, a single dose of codeine phosphate should not exceed 60 mg. For children, the usual recommended single dose is 0.5 mg/kg.

For the capsule containing 15 mg or 30 mg of codeine phosphate, the usual adult dosage is one or two capsules every four hours as needed.

For the capsule containing 60 mg of codeine phosphate, the usual adult dosage is one capsule every four hours as needed.

How is Acetaminophen Aspirin Codeine Supplied

Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/15 mg, each capsule of which contains acetaminophen 150 mg, aspirin 180 mg, and codeine phosphate 15 mg (WARNING: May be habit forming), are available as an opaque grey body and opaque green capped capsule, imprinted “LPI/LPI” in black, and are supplied in bottles of 100 capsules, NDC 46672-231-10.

Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/30 mg, each capsule of which contains acetaminophen 150 mg, aspirin 180 mg, and codeine phosphate 30 mg (WARNING: May be habit forming), are available as an opaque grey body and opaque black capped capsule, imprinted “LPI/LPI” in white, and are supplied in bottles of 100 capsules, NDC 46672-230-10.

Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/60 mg, each capsule of which contains acetaminophen 150 mg, aspirin 180 mg, and codeine phosphate 60 mg (WARNING: May be habit forming), are available as an opaque grey body and opaque red capped capsule, imprinted “LPI/LPI” in black, and are supplied in bottles of 100 capsules, NDC 46672-236-10.

Storage: Protect from moisture. Store at controlled room temperature 15-30ºC (59-86ºF).

Dispense in a tight, light-resistant container with a child-resistant closure.

CAUTION: Federal law prohibits dispensing without prescription.

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Rev. 09 / 91 Code 472Z00, 473Z00, 474Z00

ACETAMINOPHEN, ASPIRIN AND CODEINE PHOSPHATE
acetaminophen, aspirin and codeine phosphate capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	46672-231
Route of Administration	ORAL	DEA Schedule	CIII

INGREDIENTS
Name (Active Moiety)	Type	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	Active	150 MILLIGRAM In 1 CAPSULE
ASPIRIN (ASPIRIN)	Active	180 MILLIGRAM In 1 CAPSULE
CODEINE PHOSPHATE (CODEINE)	Active	15 MILLIGRAM In 1 CAPSULE
BLACK IRON DIOXIDE	Inactive
D&C YELLOW#10	Inactive
FD&C RED #40	Inactive
GELATIN	Inactive
PREGELATINIZED STARCH	Inactive
SILICON DIOXIDE	Inactive
SODIUM LAURYL SULFATE	Inactive
TITANIUM DIOXIDE	Inactive

Product Characteristics
Color	GRAY, GREEN	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	LPI;LPI
Contains
Coating	false	Symbol	false

Packaging
#	NDC	Package Description	Multilevel Packaging
1	46672-231-10	100 CAPSULE In 1 BOTTLE	None

ACETAMINOPHEN, ASPIRIN AND CODEINE PHOSPHATE
acetaminophen, aspirin and codeine phosphate capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	46672-230
Route of Administration	ORAL	DEA Schedule	CIII

INGREDIENTS
Name (Active Moiety)	Type	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	Active	150 MILLIGRAM In 1 CAPSULE
ASPIRIN (ASPIRIN)	Active	180 MILLIGRAM In 1 CAPSULE
CODEINE PHOSPHATE (CODEINE)	Active	30 MILLIGRAM In 1 CAPSULE
BLACK IRON DIOXIDE	Inactive
GELATIN	Inactive
PREGELATINIZED STARCH	Inactive
SILICON DIOXIDE	Inactive
SODIUM LAURYL SULFATE	Inactive
TITANIUM DIOXIDE	Inactive

Product Characteristics
Color	GRAY, BLACK	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	LPI;LPI
Contains
Coating	false	Symbol	false

Packaging
#	NDC	Package Description	Multilevel Packaging
1	46672-230-10	100 CAPSULE In 1 BOTTLE	None

ACETAMINOPHEN, ASPIRIN AND CODEINE PHOSPHATE
acetaminophen, aspirin and codeine phosphate capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	46672-236
Route of Administration	ORAL	DEA Schedule	CIII

INGREDIENTS
Name (Active Moiety)	Type	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	Active	150 MILLIGRAM In 1 CAPSULE
ASPIRIN (ASPIRIN)	Active	180 MILLIGRAM In 1 CAPSULE
CODEINE PHOSPHATE (CODEINE)	Active	60 MILLIGRAM In 1 CAPSULE
BLACK IRON DIOXIDE	Inactive
FD&C BLUE #1	Inactive
FD&C RED #40	Inactive
GELATIN	Inactive
PREGELATINIZED STARCH	Inactive
SILICON DIOXIDE	Inactive
SODIUM LAURYL SULFATE	Inactive
TITANIUM DIOXIDE	Inactive

Product Characteristics
Color	GRAY, RED	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	LPI;LPI
Contains
Coating	false	Symbol	false

Packaging
#	NDC	Package Description	Multilevel Packaging
1	46672-236-10	100 CAPSULE In 1 BOTTLE	None

Revised: 12/2006

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acetaminophen, dextromethorphan, guaifenesin, phenylephrine

Generic Name: acetaminophen, dextromethorphan, guaifenesin, and phenylephrine (a SEET oh MIN oh fen, DEX troe me THOR fan, gwye FEN e sin, FEN il EFF rin)

Brand names: Cold & Cough PE, Cold Head Congestion Severe Daytime, Cold Multi-Symptom Severe Daytime Cool Ice, Mucinex Children's Multi-Symptom Cold & Fever, Non-Pseudo Cold Relief, Phenflu DM, Sudafed PE Cold & Cough, Tylenol Cold & Flu Severe, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom Severe, Tylenol Cold Multi-Symptom Severe Daytime, Sudafed PE Cold & Cough, Cold & Cough PE, Tylenol Cold & Flu Severe, Mucinex Children's Multi-Symptom Cold & Fever

What is acetaminophen, dextromethorphan, guaifenesin, and phenylephrine?

Acetaminophen is a pain reliever and fever reducer.

Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.

Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

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, dextromethorphan, guaifenesin, and phenylephrine is used to treat headache, fever, body aches, cough, chest congestion, stuffy nose, and sinus congestion caused by allergies, the common cold, or the flu.

This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.

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

What is the most important information I should know about this medicine?

What should I discuss with my healthcare provider before taking this medicine?

Ask a doctor or pharmacist if it is safe for you to take acetaminophen, dextromethorphan, guaifenesin, and phenylephrine if you have:

liver disease, cirrhosis, or a history of alcoholism;

diabetes;

glaucoma;

diabetes;

epilepsy or other seizure disorder;

enlarged prostate or urination problems;

pheochromocytoma (an adrenal gland tumor); or

cough with mucus, or cough caused by emphysema or chronic bronchitis.

It is not known whether acetaminophen, dextromethorphan, guaifenesin, and phenylephrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, guaifenesin, and phenylephrine may pass into breast milk and may harm a nursing baby. Decongestants may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Artificially sweetened cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take this medicine?

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

See also: Acetaminophen, dextromethorphan, guaifenesin, phenylephrine dosage (in more detail)

What happens if I miss a dose?

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen can be fatal.

Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.

What should I avoid while taking this medicine?

This medicine side effects

chest pain, fast, slow, or uneven heart rate;

severe dizziness, feeling like you might pass out;

mood changes, confusion, hallucinations;

tremor, seizure (convulsions);

fever;

urinating less than usual or not at all;

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

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

dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

dizziness, weakness;

mild headache;

mild nausea, diarrhea, upset stomach;

dry mouth, nose, or throat;

feeling nervous, restless, irritable, or anxious; or

sleep problems (insomnia).

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, dextromethorphan, guaifenesin, phenylephrine Dosing Information

Usual Adult Dose for Cold Symptoms:

Usual Adult Dose for Influenza:

Usual Pediatric Dose for Cold Symptoms:

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg oral tablet, or
Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-100 mg-5 mg oral tablet:
12 years or older: 2 tablets orally every 4 hours not to exceed 12 tablets daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg/15 mL oral liquid:
12 years or older: 30 mL orally every 4 hours not to exceed 180 mL daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 500 mg-20 mg-400 mg-10 mg oral tablet:
6 to 11 years: 1/2 tablet orally every 4 to 6 hours not to exceed 3 tablets daily.
12 years or older: 1 tablet orally every 4 to 6 hours not to exceed 6 tablets daily.

Acetaminophen/dextromethorphan/guaifenesin/PE 325 mg-10 mg-200 mg-5 mg/10 mL oral liquid:
6 to 11 years: 10 mL orally every 4 hours not to exceed 50 mL daily.

Usual Pediatric Dose for Influenza:

What other drugs will affect this medicine?

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are also using any of the following drugs:

leflunomide (Arava);

tapentadol (Nucynta);

an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;

an antidepressant;

birth control pills or hormone replacement therapy;

blood pressure medication;

cancer medicine;

cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;

gout or arthritis medications (including gold injections);

HIV/AIDS medication;

medicines to treat psychiatric disorders;

migraine headache medicine;

an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or

seizure medication.

This list is not complete and other drugs may interact with acetaminophen, dextromethorphan, guaifenesin, and phenylephrine. 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.

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Acetaminophen, dextromethorphan, guaifenesin, phenylephrine Side Effects (in more detail)
Acetaminophen, dextromethorphan, guaifenesin, phenylephrine Dosage
Acetaminophen, dextromethorphan, guaifenesin, phenylephrine Use in Pregnancy & Breastfeeding
Acetaminophen, dextromethorphan, guaifenesin, phenylephrine Drug Interactions
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Cold Symptoms
Influenza

Where can I get more information?

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

See also: acetaminophen, dextromethorphan, guaifenesin, phenylephrine side effects (in more detail)

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid

Pronunciation: a-SEET-a-MIN-oh-fen/KLOR-fen-IR-a-meen/DEX-troe-meth-OR-fan/FEN-il-EF-rin
Generic Name: Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine
Brand Name: Dimetapp Multi-Symptom Cold and Flu

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid is used for:

Relieving symptoms of fever, headache, minor aches and pains, sinus congestion, runny nose, sneezing, itching of the nose or throat, itchy or watery eyes, sore throat, and cough due to colds, flu, hay fever, and allergies. It may also be used for other conditions as determined by your doctor.

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid is a decongestant, antihistamine, cough suppressant, and analgesic combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The analgesic and cough suppressant work in the brain to decrease pain and to reduce a dry or unproductive cough.

Do NOT use Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid if:

you are allergic to any ingredient in Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid

you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems

you are unable to urinate or are having an asthma attack

you take another product that contains acetaminophen

you take droxidopa or sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid:

Some medical conditions may interact with Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid. 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 a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat; heart disease), high or low blood pressure, low blood volume, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, or thyroid problems

if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; liver problems (eg hepatitis); an enlarged prostate or other prostate problems; trouble urinating; or glucose 6-phosphate dehydrogenase (G6PD) deficiency

if you smoke, drink more than 3 alcohol-containing drinks per day, or have a history of alcohol abuse

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

Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of bleeding, irregular heartbeat, or a heart attack may be increased

Medicines that may harm the liver (eg, acetaminophen, methotrexate, ketoconazole, isoniazid, certain medicines for HIV infection) 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

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid's side effects

Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid 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/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid:

Use Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

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/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid.

Important safety information:

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Do not drink alcohol while you use Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid.

Do not take diet or appetite control medicines while you use Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid unless your doctor tells you otherwise.

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid has acetaminophen, chlorpheniramine, dextromethorphan, and phenylephrine in it. Before you start any new medicine, check the label to see if it has any of those medicines in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid may harm your liver. Your risk may be greater if you drink alcohol while you are taking Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid. Talk to your doctor before you take Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid or other fever reducers if you drink more than 3 drinks with alcohol per day.

Do not use Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

Do NOT take more than the recommended dose or take Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid for longer than prescribed without checking with your doctor.

If new symptoms occur; if redness or swelling is present; if cough occurs with persistent rash or headache; or if your symptoms go away and come back, do not get better within 5 to 7 days, or get worse, check with your doctor.

If you have a sore throat that is severe; persists for more than 2 days; or occurs with fever, headache, rash, nausea, or vomiting, check with your doctor.

Contact your doctor if you have a fever that gets worse or lasts for more than 3 days.

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid for a few days before the tests.

Tell your doctor or dentist that you take Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid before you receive any medical or dental care, emergency care, or surgery.

Use Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, nervousness, sleeplessness, and trouble urinating.

Caution is advised when using Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid in CHILDREN; they may be more sensitive to its effects, especially excitability.

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid should not be used in CHILDREN younger than 12 years; it contains more than the recommended dose of acetaminophen for children this age and may cause liver damage.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid while you are pregnant. It is not known if Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid is found in breast milk. Do not breast-feed while taking Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid.

Possible side effects of Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid:

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:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; nausea; nervousness; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; loss of coordination; mental or mood changes (eg, depression); seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe dryness of mouth, nose, and throat; severe or persistent nervousness or trouble sleeping; shortness of breath; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; trouble urinating or inability to urinate; unusual bruising or bleeding; unusual tiredness or weakness; vision problems (eg, double vision, severe or persistent blurred vision).

See also: Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine 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 blurred vision; confusion; dark urine; hallucinations; mental or mood changes; muscle spasms; nausea, vomiting, or stomach pain; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; trouble breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid:

Store Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid 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/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid out of the reach of children and away from pets.

General information:

If you have any questions about Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid, please talk with your doctor, pharmacist, or other health care provider.

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid 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/Chlorpheniramine/Dextromethorphan/Phenylephrine Liquid. 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/Chlorpheniramine/Dextromethorphan/Phenylephrine resources

Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Side Effects (in more detail)
Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Use in Pregnancy & Breastfeeding
Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Drug Interactions
Acetaminophen/Chlorpheniramine/Dextromethorphan/Phenylephrine Support Group
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