Acetaminophen, Caffeine and Dihydrocodeine (Acetaminophen / Caffeine / Dihydrocodeine Bitartrate) - Description

Rx only

Code 790Z00

Rev. 02/99

DESCRIPTION

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are supplied in tablet form for oral administration.

Each tablet contains:

Acetaminophen..........................................................712.8 mg

Caffeine.....................................................................60 mg

Dihydrocodeine Bitartrate*..........................................32 mg

(*Warning: May be habit forming)

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                                                                                                                                                                                 M.W. = 151.17

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 (anhydrous)                                                                                           M.W. = 194.19

Dihydrocodeine bitartrate (4,5á-Epoxy-3-methoxy-17-methylmorphinan-6á-ol (+)-tartrate), an odorless, fine white powder is an opioid analgesic. It has the following structural formula:

C₁₈H₂₃NO_3•C₄H₆O₆                                                                                                  M.W. = 451.48

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, D&C Red #27 Aluminum Lake, D&C Red #30 Aluminum Lake, and FD&C Blue #1 Aluminum Lake.