ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release
GLENMARK THERAPEUTICS INC., USA
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Active ingredient (in each capsule)
Esomeprazole 20 mg
(Each delayed-release capsule corresponds to 22.250 mg esomeprazole magnesium trihydrate)
Purpose
Acid reducer
Uses
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)
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
Glenmark Therapeutics Inc., USA
Mahwah, NJ 07430
Made in India
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.
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.
ESOMEPRAZOLE MAGNESIUM
esomeprazole magnesium capsule, delayed release |
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Labeler - GLENMARK THERAPEUTICS INC., USA (969085666) |
Registrant - Graviti Pharmaceuticals Private Limited (650884781) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Graviti Pharmaceuticals Private Limited | 650884781 | MANUFACTURE(72657-124) , ANALYSIS(72657-124) |