HYDROCODONE BITARTRATE AND ACETAMINOPHEN (Page 3 of 3)

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.

The usual adult dosage for Hydrocodone Bitartrate and Acetaminophen Tablets USP is:

Product Strength	Usual Adult Dosage as needed for pain	The total 24-hour dosage should not exceed
5 mg/325 mg	One to two tablets every four to six hours	12 tablets
5 mg/500 mg	One to two tablets every four to six hours	8 tablets
7.5 mg/325 mg	One tablet every four to six hours	8 tablets
7.5 mg/500 mg	One tablet every four to six hours	6 tablets
7.5 mg/650 mg	One tablet every four to six hours	6 tablets
7.5 mg/750 mg	One tablet every four to six hours	5 tablets
10 mg/325 mg	One tablet every four to six hours	6 tablets
10 mg/500 mg	One tablet every four to six hours	6 tablets
10 mg/650 mg	One tablet every four to six hours	6 tablets
10 mg/660 mg	One tablet every four to six hours	6 tablets
10 mg/750 mg	One tablet every four to six hours	5 tablets

HOW SUPPLIED

Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/325 mg are supplied as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 5 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M357 on one side and bisected on the other side. The tablets are supplied in:

Boxes of 10×10 UD 100 NDC 63739-455-10
Boxes of 25×30 UD 750 NDC 63739-455-01

Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/325 mg are supplied as an unscored oval-shaped white tablet debossed with M366 on one side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M358 on one side and bisected on the other side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/650 mg are supplied as a capsule-shaped white tablet debossed with M359 on one side and bisected on the other side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 7.5 mg/750 mg are supplied as a capsule-shaped white tablet debossed with M360 on one side and bisected on the other side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/325 mg are supplied as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/500 mg are supplied as a capsule-shaped white tablet debossed with M363 on one side and bisected on the other side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/650 mg are supplied as a capsule-shaped blue tablet debossed with M361 on one side and bisected on the other side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/660 mg are supplied as a capsule-shaped white tablet debossed with M362 on one side and bisected on the other side.

Hydrocodone Bitartrate and Acetaminophen Tablets USP 10 mg/750 mg are supplied as a capsule-shaped white tablet debossed with M364 on one side and bisected on the other side.

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

Storage – Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

A Schedule III Narcotic.

Manufactured By:
Mallinckrodt Inc.,
Hazelwood, MO 63042 USA.

Distributed By:
McKesson Packaging Services
a business unit of McKesson Corporation
7101 Weddington Rd. Concord, NC 28027

IS-455-M72-01-A1

September 2010

REPRESENTATIVE PACKAGING

NDC 63739-455-10

Hydrocodone Bitartrate 5 mg
and Acetaminophen 500 mg
Tablets, USP CIII

UD 100 Tablets (10×10)

Rx Only

EACH TABLET CONTAINS:
Hydrocodone Bitartrate USP …………………….. 5 mg
Acetaminophen USP ……………………………..500 mg

USUAL DOSAGE: See package insert for complete dosage recommendations.

DISPENSE in a tight, light-resistant container (as defined in USP).

STORE at 20°-25°C (68°-77°F).
[see USP Controlled Room Temperature].
Protect from light.

Mfg. By: Mallinckrodt Inc., Hazelwood, MO 63042 USA

HYDROCODONE BITARTRATE AND ACETAMINOPHEN hydrocodone bitartrate and acetaminophen tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-455 Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg

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

Product Characteristics Color white Score 2 pieces Shape OVAL Size 17mm Flavor Imprint Code M357 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63739-455-10 10 BLISTER PACK (BLISTER PACK) in 1 BOX, UNIT-DOSE contains a BLISTER PACK 1 10 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-455-10) 2 NDC:63739-455-01 25 BLISTER PACK (BLISTER PACK) in 1 BOX, UNIT-DOSE contains a BLISTER PACK 2 30 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-455-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA089160 07/29/2010

Labeler — McKesson Packaging Services Business Unit of McKesson Corporation (140529962)

Establishment
Name	Address	ID/FEI	Operations
Mallinckrodt Inc.		957414238	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
McKesson Packaging Services Business Unit of McKesson Corporation		140529962	REPACK

Revised: 10/2010 McKesson Packaging Services Business Unit of McKesson Corporation