SPL Set ID: 9cbbfa94-37b9-9652-e053-2995a90a736b

Oxycodone hydrochloride and acetaminophen are available in tablets for oral administration. Each PROLATE ® , 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 Each PROLATE ® , 7.5 mg/300 mg contains: Oxycodone Hydrochloride USP….. 7.5 mg* (*7.5 mg Oxycodone Hydrochloride is equivalent to 6.7228 mg Oxycodone) Acetaminophen USP…………….. 300 mg Each PROLATE ® , 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 5 mg/300 mg strength contains D&C Yellow #10; the 7.5 mg/300 mg 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