SPL Set ID: 88d97caf-bcf5-3cde-e053-2995a90acf4a

1 drug(s) with this SPL Set ID

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oxycodone and acetaminophen OXYCODONE AND ACETAMINOPHEN
FH2 PHARMA LLC FDA Rx Only

Oxycodone hydrochloride and acetaminophen are available in tablets for oral administration. Each Oxycodone and Acetaminophen Tablet, 2.5 mg/300 mg contains: Oxycodone Hydrochloride USP….. 2.5 mg* (*2.5 mg Oxycodone Hydrochloride is equivalent to 2.2409 mg Oxycodone) Acetaminophen USP……………… 300 mg Each Oxycodone and Acetaminophen Tablet, 5 mg/300 mg contains: Oxycodone Hydrochloride USP….. 5 mg* (*5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone) Acetaminophen USP……………… 300 mg Oxycodone Hydrochloride USP….. 7.5 mg* (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone) Acetaminophen USP……………… 300 mg Each Oxycodone and Acetaminophen Tablet, 10 mg/300 mg contains: Oxycodone Hydrochloride USP….. 10 mg* (*10 mg Oxycodone Hydrochloride is equivalent to 8.9637 mg Oxycodone) Acetaminophen USP……………… 300 mg Inactive Ingredients The tablets contain: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. In addition the 2.5 mg/300 mg strength contains FD&C Blue #1 Aluminum Lake, the 5 mg/300 mg strength contains D&C Yellow #10; the 7.5 mg/300 strength contains FD&C Red# 40 Aluminum Lake; the 10 mg/300 mg strength contains FD&C Yellow #6 Aluminum Lake. Oxycodone and acetaminophen tablets contain oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is C 18 H 21 NO 4 •HCl and the molecular weight is 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula: Oxycodone and acetaminophen tablets contain acetaminophen, 4'-hydroxyacetanilide, a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is C 8 H 9 NO 2 and the molecular weight is 151.16. It may be represented by the following structural formula: oxycodone hydrochloride chemical structure acetaminophen chemical structure

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