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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

Descriptions and Administration

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 ENDOCET 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. 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 10 mg/325 mg strength may also contain corn starch.

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CONTRAINDICATIONS

ENDOCET tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus