Generic Name: acetaminophen, butalbital, caffeine, and codeine (a SEET a MIN o fen, bue TAL bi tal, KAF een, and KOE deen)
Brand Names: Fioricet with Codeine, Phrenilin with Caffeine and Codeine
What is acetaminophen, butalbital, caffeine, and codeine?
Codeine is a narcotic pain reliever. Acetaminophen is a less potent pain reliever that increases the effects of codeine.
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, caffeine, and codeine is used to treat tension headaches. This medicine is not for treating headaches that come and go.
Acetaminophen, butalbital, caffeine, and codeine may also be used for purposes not listed in this medication guide.
What is the most important information I should know about acetaminophen, butalbital, caffeine, and codeine?
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. Tell your doctor if the medicine seems to stop working as well in relieving your pain. 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. Codeine and butalbital may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it.
What should I discuss with my healthcare provider before taking acetaminophen, butalbital, caffeine, and codeine?
Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine, or if you have porphyria. Codeine and 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.
To make sure you can safely take acetaminophen, butalbital, caffeine, and codeine, tell your doctor if you have any of these other conditions:
asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
low blood pressure;
a stomach or intestinal disorder;
curvature of the spine;
mental illness; or
a history of drug or alcohol addiction.
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. FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
How should I take acetaminophen, butalbital, caffeine, and codeine?
Take exactly as prescribed. Never take this medicine in larger amounts, or for longer than recommended by your doctor. An overdose of acetaminophen 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.
One acetaminophen, butalbital, caffeine, and codeine capsule contains 325 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
Take with food or milk to ease stomach upset. Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using acetaminophen, butalbital, caffeine, and codeine. If you need surgery, tell the surgeon ahead of time that you are using this medication. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.
Keep track of the amount of medicine used from each new bottle. Acetaminophen, butalbital, caffeine, and codeine 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, caffeine, and codeine dosage (in more detail)
What happens if I miss a dose?
Since this medicine is 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. An overdose of acetaminophen, butalbital, caffeine, and codeine 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 extreme drowsiness or insomnia, restless feeling, tremors, fast heart rate, pinpoint pupils, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.
What should I avoid while taking acetaminophen, butalbital, caffeine, and codeine?
This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. 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.
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, caffeine, and codeine 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 a serious side effect such as:
shallow breathing, slow heart rate;
fast or pounding heart rate, feeling short of breath;
confusion, unusual thoughts or behavior, feeling light-headed, fainting;
muscle twitching;
easy bruising or bleeding; or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects include:
feeling dizzy or drowsy, shaky or agitated;
mild nausea, vomiting, upset stomach, constipation, diarrhea;
increased appetite, mood changes, sleep problems (insomnia); or
dry mouth, sweating, urinating more than usual.
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, caffeine, and codeine Dosing Information
Usual Adult Dose for Headache:
1 or 2 capsules orally every 4 hours, not to exceed 6 capsules per day.
What other drugs will affect acetaminophen, butalbital, caffeine, and codeine?
Do not take acetaminophen, butalbital, caffeine, and codeine with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.
Tell your doctor about all other medicines you use, especially:
glycopyrrolate (Robinul);
mepenzolate (Cantil);
ciprofloxacin (Cipro);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva);
irritable bowel medications such as dicyclomine (Bentyl) or hyoscyamine (Anaspaz, Cystospaz, and others); or
an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).
This list is not complete and other drugs may interact with acetaminophen, butalbital, caffeine, and codeine. 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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Where can I get more information?
- Your pharmacist can provide more information about acetaminophen, butalbital, caffeine, and codeine.
See also: acetaminophen, butalbital, caffeine, and codeine side effects (in more detail)
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