• Basic Info
• Top Questions
• Interactions

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 other purposes not listed in this medication guide.

Back to Top

What are the possible side effects of acetaminophen, butalbital, and caffeine?

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;

• feeling light-headed or short of breath;

• nausea, stomach pain, low fever, 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. Tell your doctor about any unusual or bothersome side effect.

Back to Top

How should I take acetaminophen, butalbital, and caffeine?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. 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. 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 tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Back to Top

What is the most important information I should know about acetaminophen, butalbital, and caffeine?
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 acetaminophen, butalbital, and caffeine before the MAO inhibitor has cleared from your body. 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 over-the-counter cough, cold, allergy, or menstrual 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 or caffeine.

Back to Top

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. 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.

Back to Top

What other drugs will affect acetaminophen, butalbital, and caffeine?
The following drugs can interact with acetaminophen, butalbital, and caffeine. Tell your doctor if you are using any of these: an antibiotic; a blood thinner such as warfarin (Coumadin); isoniazid; zidovudine (Retrovir, AZT); seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton); gout medications such as probenecid (Benemid) or sulfinpyrazone; an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

Back to Top

Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Acetaminophen-butalbital-caffeine has been assigned to pregnancy category C by the FDA. Animal reproduction studies have not been conducted on this combination product. There are no controlled data in human pregnancy. Acetaminophen-butalbital-caffeine is only recommended for use during pregnancy when benefit outweighs risk.

Acetaminophen is routinely used for short term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women compared to nonpregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production. Barbiturates in general have been reported to readily cross the placental barrier. Withdrawal seizures have been reported in a two day old infant whose mother had taken a butalbital containing drug during the last two months of pregnancy. Butalbital was found in the infant's serum. Animal reproduction studies have not been conducted on butalbital. Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies on caffeine have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit there intake of caffeine to a minimum. In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found. The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly.

Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Barbiturates are excreted in breast milk in small amounts. The significance of the effects on nursing infants has not been reported. Because of the potential for serious adverse reactions in nursing infants from butalbital, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caffeine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended.

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose.

Back to Top

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include insomnia, restlessness, tremor, dizziness, drowsiness, nausea, vomiting, diarrhea, stomach pain, loss of appetite, increased sweating, shallow breathing, confusion, uneven heartbeats, seizure (convulsions), or coma.

Back to Top

What should I discuss with my healthcare provider before taking acetaminophen, butalbital, and caffeine?
Butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be shared with 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. 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 (cirrhosis). You may not be able to take medication that contains acetaminophen.

Back to Top

Can I stop taking the medication if I feel better?
If you are taking an analgesic for pain and you are no longer experiencing the pain you may stop using the medication. In general, pain medications are to be used on an as needed basis.

Back to Top

I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

Back to Top