November 28, 2015
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How Supplied


Fioricet (butalbital, acetaminophen and caffeine) ® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.


One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.


Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP)

Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as light-blue, speckled, round uncoated tablets, engraved "FIORICET (butalbital, acetaminophen and caffeine) " on one side, and a three-head profile "" on other side. Bottles of 100 (NDC 52544-957-01) and 500 (NDC 52544-957-05).


Store below 30°C (86°F); dispense in a tight container.

*Trademark of Medical Economics Company, Inc.

Watson Pharma, Inc., A Subsidiary of Watson Pharmaceuticals, Inc.Corona, CA 92880 USA. FDA rev date: 7/18/2002

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 8/8/2011

How Supplied

Fioricet - User Reviews

Fioricet User Reviews

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Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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