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 “Imprint Code” 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 Imprint Code 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.

Principal Display Panel -- 10 mg bottle
(click image for full-size original)

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.

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