WARNINGS
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of Butalbital, Acetaminophen, and Caffeine Tablets USP is not recommended.
There is currently no manufacturer warning information available for this drug.
INDICATIONS AND USAGE
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 Butalbital, Acetaminophen, and Caffeine Tablets USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
DESCRIPTION
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:
Acetaminophen (4´-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:
Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula:
Inactive Ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
