SPL Set ID: 89b8145f-5310-4b58-a65d-586dc90d642d

1 drug(s) with this SPL Set ID

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Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ELITE LABORATORIES, 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 4,5α-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, 2.5 mg/325 mg contains: Hydrocodone Bitartrate .......... 2.5 mg Acetaminophen ...................... 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, 5 mg/325 mg contains: Hydrocodone Bitartrate .......... 5 mg Acetaminophen ...................... 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablet, 7.5 mg/325 mg contains: Hydrocodone Bitartrate ......... 7.5 mg Acetaminophen ...................... 325 mg Each Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/325 mg contains: Hydrocodone Bitartrate ........ 10 mg Acetaminophen ..................... 325 mg Inactive Ingredients The tablets contain: microcrystalline cellulose, talc, croscarmellose sodium, and magnesium stearate. Additional inactive ingredients from acetaminophen (90%) may contain pregelatinized starch, crospovidone, povidone, and stearic acid. Meets USP Dissolution Test 2.

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