SPL Set ID: 48cc1378-ffab-4645-95bb-a05d78066575
1 drug(s) with this SPL Set ID
Hydrocodone Bitartrate and Acetaminophen Tablets, USP are 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: 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: Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/300 mg contains: Hydrocodone Bitartrate ...... 5 mg Acetaminophen................. 300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/300 mg contains: Hydrocodone Bitartrate ......... 7.5 mg Acetaminophen ................ 300 mg Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/300 mg contains: Hydrocodone Bitartrate .......... 10 mg Acetaminophen.............. 300 mg In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. Meets USP Dissolution Test 2. Hydrocodone APAP