ENDOCET is indicated for the relief of moderate to moderately severe pain.

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. ENDOCET tablets are given orally.

Endocet 5 mg/325 mg; Endocet 7.5 mg/500 mg; Endocet 10 mg/650 mg

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Endocet 7.5 mg/325 mg; Endocet 10 mg/325 mg

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Cessation of Therapy

In patients treated with ENDOCET tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:

5 mg/325 mg

White, round, tablet, with one face scored and the other inscribed "Endo" and "602".

Bottles of 100                                  NDC 60951-602-70
Bottles of 500                                  NDC 60951-602-85

Unit dose package of 100 tablets NDC 60951-602-75

7.5 mg/325 mg

Peach oval-shaped, tablet debossed with “E700” on one side and “7.5/325” on the other.

Bottles of 100                                  NDC 60951-700-70

7.5 mg/500 mg

Peach, capsule-shaped, tablet debossed with “E796” on one side and “7.5” on the other.

Bottles of 100                                  NDC 60951-796-70

10 mg/325 mg

Yellow, capsule-shaped, tablet debossed with “E712” on one side and “10/325” on the other.

Bottles of 100                                  NDC 60951-712-70

10 mg/650 mg

Yellow, oval, tablet debossed with “E797” on one side and “10” on the other.

Bottles of 100                                  NDC 60951-797-70

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

DEA Order Form Required.

Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317. February, 2007. FDA rev date: n/a

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