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 the 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, USP) is supplied as follows:

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°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).

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

ZYDONE® is a Registered Trademark of Endo Pharmaceuticals Inc.

NARCAN® is Registered Trademark of Endo Pharmaceuticals Inc.

Copyright © Endo Pharmaceuticals Inc. 2002

6476-04/November, 2002

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