SPL Set ID: cc0e654d-1eaa-7d17-e053-2995a90ab1db

Hydrocodone bitartrate and acetaminophen is available in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It has the following structural formula: hbt-chemical-structure 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: apap-chemical-structure Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/300 mg contains: Hydrocodone Bitartrate. . . . . . . . 5 mg Acetaminophen. . . . . . . . . . . . . .300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/300 mg contains: Hydrocodone Bitartrate. . . . . . . . .7.5 mg Acetaminophen. . . . . . . . . . . . . . 300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/300 mg contains: Hydrocodone Bitartrate. . . . . . . . 10 mg Acetaminophen. . . . . . . . . . . . . .300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/325 mg contains: Hydrocodone Bitartrate. . . . . . . . 5 mg Acetaminophen. . . . . . . . . . . . . .325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 7.5 mg/325 mg contains: Hydrocodone Bitartrate. . . . . . . . .7.5 mg Acetaminophen. . . . . . . . . . . . . . 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, USP 10 mg/325 mg contains: Hydrocodone Bitartrate. . . . . . . . 10 mg Acetaminophen. . . . . . . . . . . . . .325 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg: This product complies with USP dissolution test 2. Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg: This product complies with USP dissolution test 1.