Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of Fioricet is not recommended.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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 Fioricet in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
There is currently no drug history available for this drug.
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
Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula:
C11H16N2O3 Mol. wt. 224.26
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
C8H9NO2 Mol. wt. 151.16
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
C8H10N4O2 Mol. wt. 194.19
Inactive Ingredients: crospovidone, FD&C Blue #1 (aluminum lake), magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.