Olmesartan Medoxomil and Hydrochlorothiazide (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Olmesartan medoxomil and hydrochlorothiazide tablets are supplied as follows:

OLM/HCTZ Shape Color Debossing
Side 1 Side 2
20/12.5 mg Round Beige OLH Plain on other side
40/12.5 mg Oval Beige OLH 12.5
40/25 mg Oval Pink OLH 25

Tablets are packaged as follows:

NDC 70756-xxx-xx
20/12.5 mg 40/12.5 mg 40/25 mg
Bottle of 30 tablets 812-30 813-30 814-30
Bottle of 90 tablets 812-90 813-90 814-90
Bottle of 500 tablets 812-51 813-51 814-51
Bottle of 1000 tablets 812-12 813-12 814-12

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

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Keep this and all medicines out of the reach of children.

17 PATIENT COUNSELING INFORMATION

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil and hydrochlorothiazide tablets 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 tablets 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.

Manufactured by: Umedica Laboratories Pvt. Ltd. Plot No. 221 and 221/1, GIDC, IInd Phase,
Vapi, Gujarat 396195, India (IND).

Made in India

Manufactured for:
Lifestar Pharma LLC
1200 MacArthur Blvd.
Mahwah, NJ 07430 USA Revised: May 2023, V-04

*The other brands listed are trademarks of their respective owners and are not trademarks of Umedica Laboratories Pvt. Ltd. The makers of these brands are not affiliated with and do not endorse Umedica Laboratories Pvt. Ltd. or its products.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20 mg/12.5 mg- NDC 70756-812-30 -30s Bottle Label

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 20mg/12.5mg 30s
(click image for full-size original)

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/12.5 mg- NDC 70756-813-90 -90s Bottle Label

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40mg/12.5mg 90s
(click image for full-size original)

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg- NDC 70756-814-12 -1000s Bottle Label

Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg 1000s
(click image for full-size original)

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-812
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYDROXYPROPYL CELLULOSE (TYPE L)
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color orange (BEIGE) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code OLH
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70756-812-30 30 TABLET in 1 BOTTLE None
2 NDC:70756-812-90 90 TABLET in 1 BOTTLE None
3 NDC:70756-812-51 500 TABLET in 1 BOTTLE None
4 NDC:70756-812-12 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208847 10/01/2020
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-813
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYDROXYPROPYL CELLULOSE (TYPE L)
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color orange (BEIGE) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code OLH;12;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70756-813-30 30 TABLET in 1 BOTTLE None
2 NDC:70756-813-90 90 TABLET in 1 BOTTLE None
3 NDC:70756-813-51 500 TABLET in 1 BOTTLE None
4 NDC:70756-813-12 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208847 10/01/2020
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE olmesartan medoxomil and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-814
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
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
HYDROXYPROPYL CELLULOSE (TYPE L)
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color pink Score no score
Shape OVAL Size 15mm
Flavor Imprint Code OLH;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70756-814-30 30 TABLET in 1 BOTTLE None
2 NDC:70756-814-90 90 TABLET in 1 BOTTLE None
3 NDC:70756-814-51 500 TABLET in 1 BOTTLE None
4 NDC:70756-814-12 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208847 10/01/2020
Labeler — Lifestar Pharma LLC (080268943)
Establishment
Name Address ID/FEI Operations
UMEDICA LABORATORIES PRIVATE LIMITED 920635096 manufacture (70756-812), manufacture (70756-813), manufacture (70756-814), analysis (70756-812), analysis (70756-813), analysis (70756-814), pack (70756-812), pack (70756-813), pack (70756-814)

Revised: 12/2023 Lifestar Pharma LLC

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