SPL Set ID: 8bc4108b-314e-4a52-a37c-631c6b869b04

1 drug(s) with this SPL Set ID

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Acetaminophen and Codeine ACETAMINOPHEN AND CODEINE
AMNEAL PHARMACEUTICALS LLC FDA Rx Only

Acetaminophen and codeine phosphate tablets, USP are supplied in tablet form for oral administration. Acetaminophen, USP, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Codeine phosphate, USP, 7,8-didehydro-4, 5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: Each Acetaminophen and Codeine Phosphate Tablet, USP (300 mg/30 mg) contains: Acetaminophen, USP .................................................. 300 mg Codeine Phosphate, USP .............................................. 30 mg In addition, each acetaminophen and codeine phosphate tablet, USP contains the following inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. 1 2

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