Clonidine Hydrochloride (Page 3 of 3)

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Address medical inquiries to: 1-888-351-3786.

Manufactured by:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA

Rev 03, April 2010

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL — 0.1 mg Bottle Label

CLONIDINE HYDROCHLORIDE TABLETS USP

0.1 mg

Rx only

PRINCIPAL DISPLAY PANEL — 0.2 mg Bottle Label

CLONIDINE HYDROCHLORIDE TABLETS USP

0.2 mg

Rx only

PRINCIPAL DISPLAY PANEL — 0.3 mg Bottle Label

CLONIDINE HYDROCHLORIDE TABLETS USP

0.3 mg

Rx only

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0048(NDC:53489-215) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO D&C YELLOW NO. 10

Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code MP;657 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-0048-1 20 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 2 NDC:54868-0048-2 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 3 NDC:54868-0048-3 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 4 NDC:54868-0048-5 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 5 NDC:54868-0048-7 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 6 NDC:54868-0048-8 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070925 10/03/2001

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0049(NDC:53489-216) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.2 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO

Product Characteristics Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code MP;658 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-0049-1 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 2 NDC:54868-0049-2 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 3 NDC:54868-0049-5 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 4 NDC:54868-0049-6 120 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 5 NDC:54868-0049-7 180 TABLET (TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070924 01/09/1995

CLONIDINE HYDROCHLORIDE clonidine hydrochloride tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1967(NDC:53489-217) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.3 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO D&C YELLOW NO. 10 FD&C BLUE NO. 1

Product Characteristics Color green Score no score Shape ROUND Size 7mm Flavor Imprint Code MP;659 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-1967-0 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 2 NDC:54868-1967-2 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 3 NDC:54868-1967-3 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 4 NDC:54868-1967-4 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None 5 NDC:54868-1967-1 120 TABLET (TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070923 11/30/2004

Labeler — Physicians Total Care, Inc. (194123980)

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

Revised: 06/2012 Physicians Total Care, Inc.