acetaminophen, butalbital, caffeine, and codeine

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 in a group of drugs called narcotic pain relievers.

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 other than those 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 drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains 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. 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.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• 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.

If you have any of these conditions, you may not be able to use acetaminophen, butalbital, caffeine, and codeine, or you may need a dosage adjustment or special tests during treatment.

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication 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. Acetaminophen, butalbital, caffeine, and codeine 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.

Older adults may be more sensitive to the effects of this medicine.

How should I take acetaminophen, butalbital, caffeine, and codeine?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

An overdose of acetaminophen can cause serious harm to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. 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 this medicine with a full glass of water. 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.

Acetaminophen, butalbital, caffeine, and codeine can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen, butalbital, caffeine, and codeine.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen, butalbital, caffeine, and codeine. You may need to stop using the medicine for a short time.

Store acetaminophen, butalbital, caffeine, and codeine at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Codeine is a drug of abuse and you should be aware if any person in the household is using this 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 acetaminophen, butalbital, caffeine, and codeine 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. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use 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. An overdose of acetaminophen, butalbital, caffeine, and codeine can be fatal.

Overdose symptoms may include extreme drowsiness or insomnia, restless feeling, tremors, fast heart rate, sweating, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking acetaminophen, butalbital, caffeine, and codeine?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. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol while taking acetaminophen, butalbital, caffeine, and codeine. Alcohol 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. Call your doctor at once if you have any of these serious side effects:

• shallow breathing, slow heart rate;

• fast or pounding heart rate, feeling short of breath;

• feeling light-headed, fainting;

• confusion, unusual thoughts or behavior;

• 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);

• sweating, urinating more than usual;

• blurred vision; or

• dry mouth.

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?

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 butalbital or codeine.

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

• 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 isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and there may be other drugs that can interact with acetaminophen, butalbital, caffeine, and codeine. 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.

Where can I get more information?

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

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 7.02. Revision Date: 4/12/2009 4:41:04 PM.