SUMMARY
Fioricet®
with Codeine
(butalbital, acetaminophen,
caffeine, and codeine
phosphate) Capsules C-III
Revised: July 2005
Rx only
Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) is supplied in capsule form for oral administration.
Each capsule contains:
codeine phosphate, USP. .. .. .. .. .. .. .. ..30 mg
butalbital, USP. .. .. .. .. .. .. .. .. .. .. .. . 50 mg
caffeine, USP. .. .. .. .. .. .. .. .. .. .. .. .. 40 mg
acetaminophen, USP. .. .. .. .. .. .. .. .. .. .325 mg
Codeine phosphate [morphine-3-methyl ether phosphate (1:1) (salt) hemihydrate, C18H24NO7P, anhydrous mw 397.37], is a narcotic analgesic and antitussive.
Butalbital (5-allyl-5-isobutylbarbituric acid, C11H16N2O3, mw 224.26), is a short- to intermediate-acting barbiturate.
Caffeine (1,3,7-trimethylxanthine, C8H10N4O2, mw 194.19), is a central nervous system stimulant.
Acetaminophen (4´-hydroxyacetanilide, C8H9NO2, mw 151.16), is a non-opiate, non-salicylate analgesic and antipyretic.
Active Ingredients: codeine phosphate, USP, butalbital, USP, caffeine, USP, and acetaminophen, USP.
Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of Fioricet® with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit-forming and potentially abusable.
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