PROLATE Tablet Ref.[108770] Active ingredients: Oxycodone and Paracetamol

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 C₁₈H₂₁NO₄•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 C₈H₉NO₂ and the molecular weight is 151.16. It may be represented by the following structural formula: