SPL Set ID: 8a201e19-3e47-7e58-e053-2995a90ab1d5

1 drug(s) with this SPL Set ID

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hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN
EYWA PHARMA INC FDA Rx Only

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 4,5-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: pregelatinized starch, colloidal silicon dioxide, povidone, crospovidone, croscarmellose sodium, stearic acid, microcrystalline cellulose, magnesium stearate, and FD&C Yellow # 6 Aluminum Lake (5 mg/300 mg only), and FD&C Blue # 1 Aluminum Lake (10 mg/300 mg only). This product complies with USP dissolution test 2. hydrocodone bitartrate chemical structure acetaminophen chemcial structure

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