Source: FDA, National Drug Code (US) Revision Year: 2016
Each tablet for oral administration contains:
Oxycodone Hydrochloride USP: 5 mg+ (+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)
Acetaminophen: 325 mg
Each 5 mL of oral solution for oral administration contains:
Oxycodone Hydrochloride: 5 mg+ (+5 mg Oxycodone Hydrochloride is equivalent to 4.4815 mg Oxycodone)
Acetaminophen: 325 mg
Alcohol: 0.4%
The tablets contain colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose and stearic acid.
The solution contains alcohol (0.4%), citric acid, disodium edetate, FD&C Red #40, flavors, fructose, polyethylene glycol, potassium sorbate, sodium saccharin and water.
ROXICET contains oxycodone, 14-hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C18H21NO4∙HCl and the molecular weight is 381.82.
It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:
ROXICET contains acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17.
It may be represented by the following structural formula:
How Supplied |
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ROXICET Tablets, Oxycodone and Acetaminophen Tablets USP (Oxycodone Hydrochloride White, round, s cored tablets (Identified 54 543). NDC 0054-8650-24: Unit dose, 25 tablets per card (reverse numbered), 4 cards per shipper. NDC 0054-4650-25: Bottles of 100 tablets. |
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