HYDROCODONE BITARTRATE AND ACETAMINOPHEN (Page 3 of 3)

DOSAGE AND ADMINISTRATION

Dosage should be adjusted according to the severity of the pain and the 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.

The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 5 tablets.

HOW SUPPLIED

Hydrocodone bitartrate and acetaminophen tablets USP, 7.5 mg/750 mg are white, capsule shaped tablets debossed with “”, “568” on one side and scored on the other side.

Bottles of 100 Tablets NDC 62037-568-01

Bottles of 500 Tablets NDC 62037-568-05

Storage: Store at controlled room temperature, 20 to 25°C (68 to 77°F) with excursions permitted to between 15 to 30°C (59 to 86°F) [see USP].

Dispense in a tight, light-resistant container as defined in the USP.

A Schedule CIII Controlled Drug Substance.

Manufactured by:
Andrx Pharmaceuticals, Inc.
Fort Lauderdale, FL 33314

Rev date: 06/07
7279

HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62037-568 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Hydrocodone Bitartrate (Hydrocodone) Hydrocodone 7.5 mg Acetaminophen (Acetaminophen) Acetaminophen 750 mg

Inactive Ingredients Ingredient Name Strength colloidal silicon dioxide corn starch (pregelatinized) croscarmellose sodium crospovidone magnesium stearate microcrystalline cellulose povidone stearic acid

Product Characteristics Color white (WHITE) Score 2 pieces Shape OVAL (Oval) Size 19mm Flavor Imprint Code 568 Contains Coating false Symbol true

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62037-568-01 100 TABLET (100 TABLET) in 1 BOTTLE None 2 NDC:62037-568-05 500 TABLET (500 TABLET) in 1 BOTTLE None

Labeler — Andrx Pharmaceuticals, Inc.

Revised: 07/2008 Andrx Pharmaceuticals, Inc.