DESCRIPTION

Oxycodone Hydrochloride and Acetaminophen are available in tablets for oral administration.

Each tablet for oral administration contains oxycodone hydrochloride and acetaminophen in the following strengths:

Oxycodone Hydrochloride, USP             2.5 mg*
(*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.)
Acetaminophen, USP                             325 mg

Oxycodone Hydrochloride, USP             5 mg*
(*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.)
Acetaminophen, USP                             325 mg

Oxycodone Hydrochloride, USP             7.5 mg*
(*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.)
Acetaminophen, USP                             325 mg

Oxycodone Hydrochloride, USP             10 mg*
(*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.)
Acetaminophen, USP                             325 mg

All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch.

Oxycodone Hydrochloride 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 Hydrochloride and Acetaminophen Tablets contain 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 151.16. It may be represented by the following structural formula:

 

Acetaminophen Structural Formula

Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:

Oxycodone Hydrochloride, USP 2.5 mg*
Acetaminophen, USP 325 mg
*2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.

Oxycodone Hydrochloride, USP 5 mg*
Acetaminophen, USP 325 mg
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.

Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 325 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.

Oxycodone Hydrochloride, USP 10 mg*
Acetaminophen, USP 325 mg
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.

All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake, and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg and 10 mg/325 mg strengths may also contain corn starch.

Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic that 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 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

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: