ESOMEPRAZOLE MAGNESIUM - esomeprazole magnesium capsule, delayed release 
Graviti Pharmaceuticals Private Limited

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MEDICATION GUIDE

Esomeprazole Magnesium Delayed-Release Capsules, USP

(es"oh mep'ra zole mag nee'zee um)

What is the most important information I should know about esomeprazole magnesium delayed-release capsules?

Esomeprazole magnesium delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.

Esomeprazole magnesium delayed-release capsules can cause serious side effects, including:

Talk to your doctor about risk of these serious side effects.

Esomeprazole magnesium delayed-release capsules can have other serious side effects. See "What are the possible side effects of esomeprazole magnesium delayed-release capsules?"

What are esomeprazole magnesium delayed-release capsules?

A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.

Esomeprazole magnesium delayed-release capsules are used in adults for:

Esomeprazole is used in children and adolescents 12 to 17 years of age for:

Esomeprazole is used in children 1 to 11 years of age for:

It is not known if esomeprazole is safe and effective in children to reduce the risk of stomach ulcers in children who take medicines called NSAIDs, to treat Helicobacter pylori stomach infection to lower the risk of a stomach ulcer returning, and to treat conditions where your stomach makes too much acid.

Do not take esomeprazole magnesium delayed-release capsules if you are:

Before taking esomeprazole magnesium delayed-release capsules, tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Especially tell your doctor if you take: clopidogrel (Plavix), methotrexate (Otrxup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), rilpivirine (EDURANT), St. John's Wort (Hypericum perforatum), or rifampin (Rimactane, Rifater, Rifamate).

How should I take esomeprazole magnesium delayed-release capsules?

What are the possible side effects of esomeprazole magnesium delayed-release capsules?

Esomeprazole can cause serious side effects, including:

The most common side effects with esomeprazole magnesium delayed-release capsules include:

These are not all the possible side effects with esomeprazole magnesium delayed-release capsules.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store esomeprazole magnesium delayed-release capsules?

Keep esomeprazole magnesium delayed-release capsules and all medicines out of the reach of children.

General information about the safe and effective use of esomeprazole magnesium delayed-release capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use esomeprazole magnesium delayed-release capsules for a condition for which it was not prescribed. Do not give esomeprazole magnesium delayed-release capsules to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about esomeprazole magnesium delayed-release capsules that is written for health professionals.

What are the ingredients in esomeprazole magnesium delayed-release capsules?

Active ingredient: esomeprazole magnesium trihydrate

Inactive ingredients in esomeprazole magnesium delayed-release capsules (including the capsule shells): hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono-and di-glycerides, polysorbate 80, sugar spheres, talc and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink also contains ferric oxide black, shellac, strong ammonium solution, potassium hydroxide and propylene glycol.

Manufactured by:

Graviti Pharmaceuticals Pvt. Ltd.

Telangana-502307, INDIA.

Manufactured for:

Graviti Pharmaceuticals Inc.,

Wilmington, Delaware-19801, USA.

All Brand names mentioned are registered trademarks of their respective owners and are not of Graviti Pharmaceuticals Private Limited.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: October 2021

Instructions for Use

Giving Esomeprazole magnesium delayed-release capsules, USP with water through a nasogastric tube (NG tube)

Esomeprazole magnesium delayed-release capsules:

This Instructions for use  has been approved by the U.S. Food and Drug Administration.

Manufactured by:

Graviti Pharmaceuticals Pvt. Ltd.

Telangana-502307, INDIA.

Manufactured for:

Graviti Pharmaceuticals Inc.,

Wilmington, Delaware-19801, USA.

Revised: 10/2021

Revised: 10/2021
Graviti Pharmaceuticals Private Limited