FIORICET SUMMARY
Fioricet®
(Butalbital, Acetaminophen,
and Caffeine Tablets USP)
Revised: October 2004
Rx only
Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets USP) is supplied in tablet form for oral administration.
Each tablet contains the following active ingredients:
butalbital USP. .. .. .. .. .. .50 mg
acetaminophen USP. .. .. . 325 mg
caffeine USP. .. .. .. .. .. . .40 mg
Fioricet® (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.
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