DESCRIPTION

Hydrocodone bitartrate and acetaminophen is 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 4,5a-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula:

Acetaminophen, 4-Hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

Hydrocodone Bitartrate and Acetaminophen Tablets USP for oral administration are available in a variety of strengths as described in the following table.

Hydrocodone
Strength	Bitartrate	Acetaminophen
2.5 mg/500 mg	2.5 mg	500 mg
5 mg/500 mg	5 mg	500 mg
7.5 mg/325 mg	7.5 mg	325 mg
7.5 mg/500 mg	7.5 mg	500 mg
7.5 mg/650 mg	7.5 mg	650 mg
7.5 mg/750 mg	7.5 mg	750 mg
10 mg/325 mg	10 mg	325 mg
10 mg/500 mg	10 mg	500 mg
10 mg/650 mg	10 mg	650 mg
10 mg/660 mg	10 mg	660 mg
10 mg/750 mg	10 mg	750 mg

In addition, each tablet contains the following inactive ingredients: anhydrous lactose, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, starch and stearic acid; except the 7.5 mg/325 mg, 10 mg/325 mg and 10 mg/500 mg tablets do not contain anhydrous lactose. The 7.5 mg/325 mg tablets include FD&C Yellow #6 Aluminum Lake; the 7.5 mg/650 mg tablets include FD&C Red #40 Aluminum Lake; the 10 mg/325 mg and 10 mg/750 mg tablets include D&C Yellow #10 Aluminum Lake; the 10 mg/500 mg tablets include FD&C Blue #2 Aluminum Lake; and the 10 mg/650 mg tablets include FD&C Blue #1 Aluminum Lake and D&C Yellow #10 Aluminum Lake. Meets USP Dissolution Test 1.