Amlodipine and Olmesartan Medoxomil (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC: 63629-8218-1: 30 Tablets in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to amlodipine and olmesartan medoxomil during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

Lactation : Advise nursing women not to breastfeed during treatment with amlodipine and olmesartan medoxomil [see Use in Specific Populations (8.2)].

Potassium Supplements : Advise patients not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider.

Maalox® is a registered trademark of Novartis Consumer Health, Inc.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 038, India Revised: 12/2020

Amlodipine /Olmesartan 5/20mg Tab.

Label
(click image for full-size original)
AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8218(NDC:65862-854)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
POLYETHYLENE GLYCOL 3350
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code K;27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-8218-1 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206906 05/15/2017
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-8218), RELABEL (63629-8218)

Revised: 12/2021 Bryant Ranch Prepack

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.