Hydrocodone Bitartate 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 or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 12 tablets.

HOW SUPPLIED

Hydrocodone Bitartrate and Acetaminophen Tablets, USP 2.5mg/325mg are supplied as white, capsule shaped, debossed “2.5/325” on one side and “KLE” on the other side, in bottles of 30 tablets, NDC 42254-300-30, bottles of 60 tablets, NDC 42254-300-60 and bottles of 90 tablets, NDC 42254-300-90.

Storage:

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

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

A Schedule CIII Narcotic

Rx Only

Manufactured by:

MIKART, INC.

Atlanta, GA 30318

Manufactured for:

KLE 2, Inc.
Culver City, CA 90232

Repackage by:

REBEL DISTRIBUTORS, CORP.
Thousand Oaks, CA 91320

Principal Display Panel

HYDROCODONE BITARTATE AND ACETAMINOPHEN hydrocodone bitartrate, acetaminophen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-300(NDC:76218-1828) Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 2.5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSPOVIDONE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE STARCH, CORN STEARIC ACID

Product Characteristics Color white (WHITE) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code 2;5;325;KLE Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42254-300-30 30 TABLET in 1 BOTTLE, PLASTIC None 2 NDC:42254-300-60 60 TABLET in 1 BOTTLE, PLASTIC None 3 NDC:42254-300-90 90 TABLET in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040846 05/17/2012

Labeler — Rebel Distributors Corp (118802834)

Registrant — PSS World Medical, Inc. (101822862)

Establishment
Name	Address	ID/FEI	Operations
PSS World Medical, Inc.		791528623	REPACK (42254-300)

Establishment
Name	Address	ID/FEI	Operations
STAT RX USA LLC		786036330	REPACK (42254-300)

Establishment
Name	Address	ID/FEI	Operations
Dispensing Solutions, Inc.		066070785	RELABEL (42254-300), REPACK (42254-300)

Establishment
Name	Address	ID/FEI	Operations
SCRIPT PAK		964420108	RELABEL (42254-300), REPACK (42254-300)

Establishment
Name	Address	ID/FEI	Operations
Keltman Pharmaceuticals, Inc.		362861077	REPACK (42254-300)

Establishment
Name	Address	ID/FEI	Operations
Rebel Distirbutors Corp.		118802834	RELABEL (42254-300), REPACK (42254-300)

Revised: 07/2012 Rebel Distributors Corp