16 HOW SUPPLIED/STORAGE AND HANDLING
Olmesartan medoxomil and hydrochlorothiazide tablets 20 mg/12.5 mg are reddish-yellow, round shaped, biconvex film-coated tablets, debossed with ‘K’ on one side and ‘23’ on the other side.
Bottles of 30 NDC 65862-779-30
Bottles of 90 NDC 65862-779-90
Bottles of 1,000 NDC 65862-779-99
10 x 10 Unit-dose Tablets NDC 65862-779-78
Olmesartan medoxomil and hydrochlorothiazide tablets 40 mg/12.5 mg are reddish-yellow, oval shaped, biconvex film-coated tablets, debossed with ‘K’ on one side and ‘53’ on the other side.
Bottles of 30 NDC 65862-780-30
Bottles of 90 NDC 65862-780-90
Bottles of 1,000 NDC 65862-780-99
10 x 10 Unit-dose Tablets NDC 65862-780-78
Olmesartan medoxomil and hydrochlorothiazide tablets 40 mg/25 mg are pink, oval shaped, biconvex film-coated tablets, debossed with ‘K’ on one side and ‘54’ on the other side.
Bottles of 30 NDC 65862-781-30
Bottles of 90 NDC 65862-781-90
Bottles of 1,000 NDC 65862-781-99
10 x 10 Unit-dose Tablets NDC 65862-781-78
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Pregnancy: Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil and hydrochlorothiazide during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Use in Specific Populations (8.1)].
Symptomatic hypotension and syncope: Advise patients that lightheadedness can occur, especially during the first days of therapy, and to report this symptom to a healthcare provider. Inform patients that dehydration from inadequate fluid intake, excessive perspiration, vomiting, or diarrhea may lead to an excessive fall in blood pressure. If syncope occurs advise patients, to contact their healthcare provider.
Potassium Supplements: Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.
Acute myopia and secondary angle-closure glaucoma : Advise patients to discontinue olmesartan medoxomil and hydrochlorothiazide and seek immediate medical attention if they experience symptoms of acute myopia or secondary angle-closure glaucoma [see Warnings and Precautions (5.6)].
Non-melanoma Skin Cancer: Instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India
Revised: 09/2020
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg/12.5 mg (30 Tablets Bottle)
NDC 65862-779-30
Rx only
Olmesartan Medoxomil
and Hydrochlorothiazide
Tablets
20 mg/12.5 mg
AUROBINDO 30 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg/12.5 mg (30 Tablets Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)
NDC 65862-779-78
Rx only
Olmesartan Medoxomil and
Hydrochlorothiazide Tablets
20 mg/12.5 mg
AUROBINDO 100 (10 x 10) Unit-dose Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg/12.5 mg (30 Tablets Bottle)
NDC 65862-780-30
Rx only
Olmesartan Medoxomil
and Hydrochlorothiazide
Tablets
40 mg/12.5 mg
AUROBINDO 30 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg/12.5 mg Blister Carton (10 x 10 Unit-dose)
NDC 65862-780-78
Rx only
Olmesartan Medoxomil and
Hydrochlorothiazide Tablets
40 mg/12.5 mg
AUROBINDO 100 (10 x 10) Unit-dose Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg/25 mg (30 Tablets Bottle)
NDC 65862-781-30
Rx only
Olmesartan Medoxomil
and Hydrochlorothiazide
Tablets
40 mg/25 mg
AUROBINDO 30 Tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 40 mg/25 mg Blister Carton (10 x 10 Unit-dose)
NDC 65862-781-78
Rx only
Olmesartan Medoxomil and
Hydrochlorothiazide Tablets
40 mg/25 mg
AUROBINDO 100 (10 x 10) Unit-dose Tablets
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet, film coated |
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OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet, film coated |
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OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet, film coated |
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Revised: 09/2020 Aurobindo Pharma Limited