Butalbital, Acetaminophen and Caffeine (Butalbital / Acetaminophen / Caffeine) - Description

Rx Only

Code 886A00          Rev. 01/03

DESCRIPTION

Butalbital, Acetaminophen and Caffeine Tablets, USP is 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. It has the following structural formula:

C₁₁H₁₆N₂O₃                                                                                                                   MW = 224.26

Acetaminophen (4'‑hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non‑opiate, non‑salicylate analgesic and antipyretic. It has the following structural formula:

C₈H₉NO₂                                                                                                                     MW = 151.16

Caffeine (1,3,7‑trimethylxanthine), a bitter, white powder or white‑glistening needles, is a central nervous system stimulant. It has the following structural formula:

C₈H₁₀N₄O₂                                                                                                                MW = 194.19

Each Butalbital, Acetaminophen and Caffeine Tablet, USP contains:

Butalbital......…....................................50 mg

Warning: May be habit-forming.

Acetaminophen ………………………750 mg

Caffeine ………………………………40 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized corn starch and stearic acid. Film coating composed of: carnauba wax, hypromellose, polyethylene glycol, titanium dioxide, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, D&C Red No. 30 aluminum lake.