Hydrocodone and Acetaminophen (Hydrocodone Bitartrate / Acetaminophen) - Description

Rx only

Code 558B00                                                                                                               Rev. 04/03

DESCRIPTION

Hydrocodone bitartrate and acetaminophen are supplied in tablet form for oral administration.

Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is: 4,5 α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

C₁₈H₂₁NO₃• C₄H₆O₆• 2½H₂O                                                                                    M.W. 494.490

Acetaminophen, 4´-hydroxy-acetanilide, 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. 151.16

Each tablet contains:

Hydrocodone Bitartrate..................10 mg

WARNING: May be habit- forming.

Acetaminophen..............................650 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid and FD&C Blue #1 Lake.

This product complies with Dissolution Test 1.