Zydone
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Zydone
INDICATIONS
ZYDONE (hydrocodone bitartrate and acetaminophen) (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
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. June, 2003. FDA Rev date: 11/27/1998
Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Zydone Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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