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Butalbital Acetaminophen and Caffeine (byoo-TAL-bi-tal and a-seat-a-MIN-oh-fen) combination is a pain reliever and relaxant. Butalbital Acetaminophen and Caffeine is used to treat tension headaches. Butalbital Acetaminophen and Caffeine 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 Acetaminophen and Caffeine for a long time, your body may get used to it so that larger amounts  are needed to produce the same effects. This is called tolerance to the  medicine. Also, Butalbital Acetaminophen and Caffeine may become habit-forming (causing mental or physical dependence) when Butalbital Acetaminophen and Caffeine is used for a long time or in large doses. Physical dependence may lead to withdrawal side effects when you stop taking Butalbital Acetaminophen and Caffeine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.

Some Butalbital Acetaminophen and Caffeine combinations also contain caffeine (KAF-een) . Caffeine may help to  relieve headaches. However, caffeine can also cause physical dependence  when it is used for a long time. This may lead to withdrawal (rebound)  headaches when you stop taking it.

Butalbital Acetaminophen and Caffeine combination may also be used for other kinds of headaches or other kinds of pain as determined by your doctor.

Butalbital Acetaminophen and Caffeine combinations are available only with your doctor's prescription in the following dosage forms:

* Oral Butalbital Acetaminophen and Caffeine
          o Capsules (U.S.)
          o Tablets (U.S.)
          * Butalbital Acetaminophen and Caffeine
          o Capsules (U.S.)
          o Tablets (U.S.)

In deciding to use Butalbital Acetaminophen and Caffeine, the risks of taking Butalbital Acetaminophen and Caffeine must be weighed against the good it will do. This is a decision you and your doctor will make. For Butalbital Acetaminophen and Caffeine combinations, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to Butalbital Acetaminophen and Caffeine or other barbiturates, or to acetaminophen, aspirin, or caffeine. Also  tell your health care professional if you are allergic to any other  substances, such as foods, preservatives, or dyes.

Pregnancy—

* For Butalbital Acetaminophen and Caffeine: Barbiturates such as Butalbital Acetaminophen and Caffeine have been shown to increase the chance of birth defects in humans.  Also, one study in humans has suggested that barbiturates taken during  pregnancy may increase the chance of brain tumors in the baby. Butalbital Acetaminophen and Caffeine may cause breathing problems in the newborn baby if taken just before or during delivery.
          * For acetaminophen: Although studies on birth defects with  acetaminophen have not been done in pregnant women, it has not been  reported to cause birth defects or other problems.
          * For caffeine: Studies in humans have not shown that caffeine  (contained in some of these combination medicines) causes birth  defects. However, use of large amounts of caffeine during pregnancy may  cause problems with the heart rhythm and the growth of the fetus. Also,  studies in animals have shown that caffeine causes birth defects when  given in very large doses (amounts equal to those present in 12 to 24  cups of coffee a day).

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