SPL Set ID: 392a846e-7325-462d-b19b-8afda44c5cb0

1 drug(s) with this SPL Set ID

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Hydrocodone Bitartrate and Acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AUROLIFE PHARMA, LLC FDA Rx Only

Hydrocodone bitartrate and acetaminophen 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 nonopiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Hydrocodone Bitartate and Acetaminophen Tablets USP is available in the following strengths: Acetaminophen USP…………………. 300 mg Hydrocodone Bitartrate USP………… 5 mg WARNING: May be habit-forming. Acetaminophen USP…………………. 300 mg Hydrocodone Bitartrate USP………… 7.5 mg WARNING: May be habit-forming. Acetaminophen USP…………………. 300 mg Hydrocodone Bitartrate USP………… 10 mg WARNING: May be habit-forming. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize) and stearic acid. This product complies with USP Dissolution Test 1. Chemical Structure Chemical Structure

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