Olmesartan Medoxomil (Page 5 of 5)

17 PATIENT COUNSELING INFORMATION

Pregnancy: Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil 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 Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].

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

Hyperkalemia: Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting their healthcare provider [see Drug Interactions (7.1)].

Manufactured by:

Alkem Laboratories Ltd.

Mumbai — 400 013, INDIA


Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Relabeled by:

Proficient RX LP

Thousand Oaks, CA 91320

Revised: December, 2019

Rx Only

PT 2245-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only
NDC 71205-458-30
Olmesartan Medoxomil Tablets 20 mg 30 Tablets

71205-458-30
(click image for full-size original)

Rx only
NDC 71205-459-30
Olmesartan Medoxomil Tablets 40 mg 30 Tablets

71205-459-30
(click image for full-size original)
OLMESARTAN MEDOXOMIL olmesartan medoxomil tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-458(NDC:67877-446)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (90000 WAMW)
STEARIC ACID
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (round shape) Size 9mm
Flavor Imprint Code OLM;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-458-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206763 04/24/2017
OLMESARTAN MEDOXOMIL olmesartan medoxomil tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-459(NDC:67877-447)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (90000 WAMW)
STEARIC ACID
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (oval shape) Size 15mm
Flavor Imprint Code OLM;40
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-459-30 30 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206763 04/24/2017
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-458), RELABEL (71205-458), REPACK (71205-459), RELABEL (71205-459)

Revised: 06/2020 Proficient Rx LP

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