Zydone (Hydrocodone Bitartrate / Acetaminophen) - Indications and Dosage

INDICATIONS AND USAGE

ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is indicated for the relief of moderate to moderately severe pain.

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to severity of pain and response of the patient. However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

5 mg/400 mg: The usual adult dose is one or two tablets every four to six hours as needed for pain.

The total daily dosage should not exceed eight tablets.

7.5 mg/400 mg: The usual adult dosage is one tablet every four to six hours as needed for pain.

The total daily dosage should not exceed six tablets.

10 mg/400 mg: The usual adult dosage is one tablet every four to six hours as needed for pain.

The total daily dosage should not exceed six tablets.

HOW SUPPLIED

ZYDONE (hydrocodone bitartrate and acetaminophen tablets) is supplied as follows:

5 mg/400 mg

Yellow, elongated octagonal, convex tablets debossed with “E” on one side and “5” on the other.

Bottles of 100         NDC 63481-668-70

7.5 mg/400 mg

Blue, elongated octagonal, convex tablets debossed with “E” on one side and “7.5” on the other.

Bottles of 100         NDC 63481-669-70

10 mg/400 mg

Red, elongated octagonal, convex tablets debossed with “E” on one side and “10” on the other.

Bottles of 100         NDC 63481-698-70

Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.]

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

A Schedule III Opioid. Oral prescription where permitted by state law.

Manufactured for:

Endo Pharmaceuticals Inc.

Chadds Ford, Pennsylvania 19317

ZYDONE^® is a Registered Trademark of Endo Pharmaceuticals Inc.

NARCAN^® is a Registered Trademark of Endo Pharmaceuticals Inc.

Copyright © Endo Pharmaceuticals Inc. 2003

Printed in U.S.A.

413742/June, 2003