TUSSICAPS (Page 3 of 3)

HOW SUPPLIED

Full-Strength: 10 mg/8 mg

TussiCaps^® (hydrocodone polistirex and chlorpheniramine polistirex) extended-release capsules

Each full-strength capsule contains hydrocodone polistirex equivalent to 10 mg hydrocodone bitartrate and chlorpheniramine polistirex equivalent to 8 mg chlorpheniramine maleate. It is available as an Ivory/Ivory capsule printed in blue with “” on the cap and “HP/CP” over “10/8” on the body.

Bottles of 20…………………………………NDC 54868-5957-0

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

Dispense in a well-closed container.

A Schedule CIII Narcotic.

For Medical Information

Contact: Product Monitoring Department
Phone: 800-778-7898

Manufactured by:
Mallinckrodt Inc.
Hazelwood, Missouri
63042 U.S.A.

COVIDIEN, COVIDIEN with Logo, TussiCaps and are trademarks of Covidien AG or an affiliate.

© 2008 Covidien AG or an affiliate. All rights reserved.

Rev 060308

COVIDIEN
Mallinckrodt

Additional barcode labeling by:

Physicians Total Care, Inc.

Tulsa, Oklahoma 74146

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL — 10 mg/8 mg Bottle

NDC 54868-5957-0
20 CAPSULES
TussiCaps ®
(Hydrocodone Polistirex and Chlorpheniramine Polistirex)
Extended-Release Capsules
CIII
10 mg/8 mg (full-strength)
Contraindicated in children under 6 years of age.
Each capsule contains:
Hydrocodone Polistirex equivalent to 10 mg hydrocodone bitartrate
Chlorpheniramine Polistirex equivalent to 8 mg chlorpheniramine maleate
Rx only
This package is not for household use.

TUSSICAPS hydrocodone polistirex and chlorpheniramine polistirex capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5957(NDC:23635-108) Route of Administration ORAL DEA Schedule CIII

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE 10 mg CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE 8 mg

Inactive Ingredients Ingredient Name Strength BUTYL ALCOHOL GELATIN FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL CELLULOSE, MICROCRYSTALLINE PROPYLENE GLYCOL WATER SHELLAC AMMONIA TITANIUM DIOXIDE D&C YELLOW NO. 10 ALUMINUM OXIDE FD&C BLUE NO. 1 FD&C BLUE NO. 2 INDIGOTINDISULFONATE SODIUM FD&C RED NO. 40 ALCOHOL METHYL ALCOHOL

Product Characteristics Color white, white (ivory) Score no score Shape CAPSULE Size 20mm Flavor Imprint Code M;HP;CP;10;8 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-5957-0 20 CAPSULE, EXTENDED RELEASE (CAPSULE) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077273 10/27/2008

Labeler — Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Operations
Physicians Total Care, Inc.		194123980	relabel

Revised: 06/2012 Physicians Total Care, Inc.