Benicar Hct (Page 4 of 4)

HOW SUPPLIED

BENICAR HCT ^® is supplied as 20 mg/12.5 mg: reddish-yellow, circular, film-coated tablets, approximately 8.5 mm in diameter, with “Sankyo” debossed on one side and “C22” on the other side. Each tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

40 mg/12.5 mg: reddish-yellow, oval, film-coated tablets, approximately 15 x 7 mm, with “Sankyo” debossed on one side and “C23” on the other side. Each tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

40 mg/25 mg: pink, oval, film-coated tablets, approximately 15 x 7 mm, with “Sankyo” debossed on one side and “C25” on the other side. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

Tablets are supplied as follows:

	20 mg/12.5 mg	40 mg/12.5 mg	40 mg/25 mg
Bottle of 30 tablets	NDC 54868-5170-0	NDC 54868-5075-0	NDC 54868-5078-0
Bottle of 90 tablets	NDC 54868-5170-1	NDC 54868-5075-1	NDC 54868-5078-1

Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature].

Manufactured for Daiichi Sankyo, Inc., Parsippany, NJ 07054

Rx Only

Copyright © Daiichi Sankyo, Inc. 2006. All rights reserved.

P1800706 Rev. December 2006

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

PRINCIPAL DISPLAY PANEL

BENICAR HCT ^®

20 mg/12.5 mg

40 mg/12.5 mg

40 mg/25 mg

BENICAR HCT olmesartan medoxomil and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5170(NDC:65597-105) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE HYPROMELLOSES LACTOSE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW

Product Characteristics Color yellow (reddish-yellow) Score no score Shape ROUND (round) Size 9mm Flavor Imprint Code Sankyo;C22 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-5170-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None 2 NDC:54868-5170-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021532 10/15/2004

BENICAR HCT olmesartan medoxomil and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5075(NDC:65597-106) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg

Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE HYPROMELLOSES LACTOSE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW

Product Characteristics Color yellow (reddish-yellow) Score no score Shape OVAL (oval) Size 15mm Flavor Imprint Code Sankyo;C23 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-5075-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None 2 NDC:54868-5075-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021532 06/01/2004

BENICAR HCT olmesartan medoxomil and hydrochlorothiazide tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5078(NDC:65597-107) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg

Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE HYPROMELLOSES LACTOSE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE FERRIC OXIDE RED TALC TITANIUM DIOXIDE FERRIC OXIDE YELLOW

Product Characteristics Color pink (pink) Score no score Shape OVAL (oval) Size 15mm Flavor Imprint Code Sankyo;C25 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54868-5078-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None 2 NDC:54868-5078-1 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021532 06/02/2004

Labeler — Physicians Total Care, Inc. (194123980)

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

Revised: 11/2010 Physicians Total Care, Inc.