ROXICET Tablet / Oral solution Ref.[10630] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2016 

Product description

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%

Inactive Ingredients

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

ROXICET Tablets, Oxycodone and Acetaminophen Tablets USP (Oxycodone Hydrochloride
5 mg and Acetaminophen 325 mg).

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.
NDC 0054-4650-29: Bottles of 500 tablets

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