SUMMARY
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP
50 mg/750 mg/40 mg
Butalbital, acetaminophen and caffeine are supplied in tablet form for oral administration.
Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate acting barbiturate.
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, nonsalicylate analgesic and antipyretic.
Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant.
Each tablet contains:
Butalbital...................50 mg
Warning: May be habit-forming.
Acetaminophen........325 mg
Caffeine......................40 mg
Butalbital, acetaminophen and caffeine tablets are 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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