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Special warnings about this medication
Check with your doctor:

If the medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the medicine. Do not tr y to get better pain relief by increasing the dose.

If you are having headaches more often than you did before you started taking this medicine. This is especially important if a new headach e occurs within 1 day after you took your last dose of this medicine, headaches begin to occur every day, or a headache continues for several days in a row. This may mean that you are dependent on the medicine. Continuing to take this medicine will cause even more headaches later on. Your doctor can give you advice on how to relieve the headaches.

Significant Interactions:
Do not take acetaminophen / butalbital / caffeine -Fioricet if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. Acetaminophen and butalbital may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), other pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine unless your do ctor approves. Many other medicines contain acetaminophen, especially over-the-counter pain, fever, cold, and allergy medications. Too much acetaminophen can be very dangerous. Drugs other than those

What special precautions should I follow?
Children¡X

- For butalbital: Although barbiturates such as butalbital often cause drowsiness, some children become excited after taking them.
- For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.
- For caffeine: There is no specific information comparing use o f caffeine in children up to 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

What side effects may occur?
If you experience any of the following serious side effects, stop taking acetaminophen / butalbital / caffeine - Fioricet and seek emergency medical attention: an allergic reaction (difficulty breathi ng; closing of your throat; swelling of your lips, tongue, or face; or hives); slow, weak breathing; liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleedin g or bruising, severe fatigue); blood problems (easy or unusual bleeding or bruising); or low blood sugar (fatigue, increased hunger or thirst,

Why is this medication prescribed?
Butalbital and acetaminophen (byoo-TAL-bi-tal and a-seat-a-MIN-oh-fen) combination is a pain reliever and relaxant. It is used to treat tension headaches. Butalbital belongs to the group of medicines called barbiturates (bar-BI-tyoo-rates) . Barbiturates act in the central nervous system (CNS) to produce their effects.

When you take butalbital for a long time, your body may get used to i t so that larger amounts are needed to produce the same effects. This is called tolerance to the medicine. Also, butalbital may become habit-forming (causing mental or physical dependence) when it is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.






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