ZEBUTAL SUMMARY
ZEBUTAL™ CAPSULES BRAND OF
BUTALBITAL, ACETAMINOPHEN, AND
CAFFEINE CAPSULES, USP
ZEBUTAL™ Capsules brand of Butalbital, Acetaminophen, and Caffeine is supplied in capsule form for oral administration. Each ZEBUTAL™ Capsule contains:
- Butalbital, USP...........................................50 mg
- Acetaminophen, USP...............................500 mg
- Caffeine, USP.............................................40 mg
Butalbital (5-allyl-5-isobutylbarbituric acid), a white, odorless, crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate.
Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
Caffeine (1,3,7,-trimethylxanthine), a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant.
ZEBUTAL™ Capsules 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.
|
