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.
| AMLODIPINE AND OLMESARTAN MEDOXOMIL amlodipine and olmesartan medoxomil tablet, film coated | ||||||||||||||||||||||||
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| 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
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