#
Butalbital,Aspirin and Caffeine Capsule
  • Professionals
  • FDA PI

Butalbital,Aspirin and Caffeine Capsule

Dosage form: capsule
Drug class:Analgesic combinations

Medically reviewed by Drugs.com. Last updated on Oct 1, 2021.

Butalbital,Aspirin and Caffeine Capsule Description

Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule form for oral administration.

Each capsule contains the following active ingredients:

butalbital, USP . . . . . . . . . . . . 50 mg

aspirin, 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:

Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. 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:lactose monohydrate, pregelatinized maize starch, sodium starch glycolate and talc. Gelatin capsule contains yellow iron oxide, FD&C Blue # 2, titanium dioxide and gelatin.

The imprinting ink contains the following: black iron oxide, D&C Yellow # 10 Aluminum Lake, FD&C Blue #1/ Brilliant Blue FCF Aluminum Lake, FD&C Blue #2/ Indigo Carmine Aluminum Lake, FD&C Red # 40/ Allura Red AC Aluminum Lake, propylene glycol and shellac glaze.

Butalbital,Aspirin and Caffeine Capsule - Clinical Pharmacology

Pharmacologically, Butalbital, Aspirin, and Caffeine Capsules combines the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital.

The clinical effectiveness of Butalbital, Aspirin, and Caffeine Capsules in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared Butalbital, Aspirin, and Caffeine Capsules with each of its major components. This study demonstrated that each component contributes to the efficacy of Butalbita...