DESCRIPTION
ZYDONE (hydrocodone bitartrate and acetaminophen tablets) for oral administration, contain hydrocodone bitartrate and acetaminophen in the following strengths:
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Hydrocodone Bitartrate, USP
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5 mg
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Acetaminophen, USP
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400 mg
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Hydrocodone Bitartrate, USP
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7.5 mg
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Acetaminophen, USP
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400 mg
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Hydrocodone Bitartrate, USP
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10 mg
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Acetaminophen, USP
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400 mg
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In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. The 5 mg/400 mg strength contains FD&C Yellow No. 10; 7.5 mg/400 mg contains FD&C Blue No. 2; and 10 mg/400 mg contains FD&C Red No. 40.
Zydone Tablets meet USP Dissolution Test 1.
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or as a crystalline powder. It is affected by light. The chemical name is 4,5(alpha)-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:
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