PROLATE Oral solution Ref.[10478] Active ingredients: Oxycodone Oxycodone and Paracetamol Paracetamol

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

Oxycodone hydrochloride and acetaminophen are available in liquid form for oral administration.

Each 5 mL of Prolate for oral administration contains:

Oxycodone hydrochloride USP: 10 mg*

* 10 mg oxycodone hydrochloride is equivalent to 8.9637 mg oxycodone

Acetaminophen USP: 300 mg

Inactive Ingredients

The solution contains: anhydrous citric acid, edetate disodium, fructose, glycerin, polyethylene glycol, potassium sorbate, propylene glycol, purified water, saccharin sodium with FD&C Red #40 as coloring and tropical fruit punch flavoring.

Oxycodone hydrochloride and acetaminophen oral solution contains 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 C18H21NO4ยทHCl 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 hydrochloride and acetaminophen oral solution contains acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. 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

Prolate (oxycodone hydrochloride and acetaminophen oral solution), each 5 mL (teaspoonful) of which contains oxycodone hydrochloride 10 mg and acetaminophen 300 mg, is supplied as a red, tropical fruit punch flavored liquid in 120 mL bottles, NDC 72245-648-12 and 500 ml bottles, NDC 72245-648-50.

Distributed by: Forte Bio-Pharma LLC, Las Vegas, NV 89113

Drugs

Drug Countries
PROLATE United States

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