ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release 
GLENMARK THERAPEUTICS INC., USA

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Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Esomeprazole Magnesium Drug Facts

Drug Facts

Active ingredient (in each capsule)

Esomeprazole 20 mg

(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)

Purpose

Acid reducer

Uses

Warnings

Allergy alert:

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use if you have

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

14-Day Course of Treatment Repeated 14-Day Courses (if needed)

Other Information

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg:

FD&C Blue 2, Gelatin, Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion, Mono-and Di-Glycerides, Pharmaceutical Ink, Polysorbate 80, Sugar Spheres, Talc, Triethyl Citrate.

Questions or comments?

Call Toll-free weekdays 9AM to 5PM EST at 1-888-721-7115

Contact Glenmark Therapeutics Inc., USA or www.glenmarkpharma-us.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Made in India

Additional Information

KEEP CARTON FOR COMPLETE WARNINGS AND IMPORTANT INFORMATION.

Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or Blue band around the center of each capsule is broken or missing.

Tips for Managing Heartburn

Marketed for:

Glenmark Therapeutics Inc., USA

Mahwah, NJ 07430

Made in India

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 20 mg Capsules: Container Label

NDC 72657-124-14

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 Days for Full effect

24 HR

14 Capsules

One 14-day Course of Treatment

See New Warning Information

Manufactured for Glenmark Therapeutics Inc., USA

Made in India.

image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel - 14 Capsule Carton label

NDC 73657-124-42

Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg

Acid Reducer

Treats Frequent Heartburn

May take 1 to 4 Days for Full effect

24 HR

14 Capsules

One 14-day Course of Treatment

See New Warning Information

Manufactured for Glenmark Therapeutics Inc., USA

Made in India.

image
ESOMEPRAZOLE MAGNESIUM 
esomeprazole magnesium capsule, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72657-124
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT) ESOMEPRAZOLE20 mg
Inactive Ingredients
Ingredient NameStrength
RAW SUGAR (UNII: 8M707QY5GH)  
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
TALC (UNII: 7SEV7J4R1U)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
Product Characteristics
ColorWHITE (white opaque colored) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code 20mg;223
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72657-124-423 in 1 CARTON08/22/2023
114 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21634908/22/2023
Labeler - GLENMARK THERAPEUTICS INC., USA (969085666)
Registrant - Graviti Pharmaceuticals Private Limited (650884781)
Establishment
NameAddressID/FEIBusiness Operations
Graviti Pharmaceuticals Private Limited650884781MANUFACTURE(72657-124) , ANALYSIS(72657-124)

Revised: 5/2023
Document Id: 4744704a-027c-4925-9d57-99b4434fc946
Set id: ff233fbb-716d-4879-811c-c8d82e3c99ce
Version: 1
Effective Time: 20230525
 
GLENMARK THERAPEUTICS INC., USA