OMEPRAZOLE - omeprazole capsule, delayed release 
Zydus Pharmaceuticals (USA) Inc.

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MEDICATION GUIDE

Omeprazole (oh mep' ra zole) Delayed-Release Capsules, USP

Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.

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

You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed.

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

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

Omeprazole delayed-release capsules can have other serious side effects. See "What are the possible side effects of omeprazole delayed-release capsules?"

What are omeprazole delayed-release capsules?

Omeprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduce the amount of acid in your stomach.

Omeprazole delayed-release capsules are used in adults:

For children 1 to 16 years of age, omeprazole delayed-release capsules are used:

For children 1 month to less than 12 months (1 year) of age, omeprazole delayed-release capsules is used:

Who should not take omeprazole delayed-release capsules?

Do not take omeprazole delayed-release capsules if you:

What should I tell my doctor before taking omeprazole delayed-release capsules?

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

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take omeprazole delayed-release capsules?

Omeprazole Delayed-Release Capsules

If you miss a dose of omeprazole delayed-release capsules, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose.

If you take too much omeprazole delayed-release capsules, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.

What are the possible side effects of omeprazole delayed-release capsules? Omeprazole delayed-release capsules can cause serious side effects, including:

Tell your doctor right away if you develop any of these symptoms:

Your doctor may check the level of magnesium in your body before you start taking omeprazole delayed-release capsules or during treatment if you will be taking omeprazole delayed-release capsules for a long period of time.

The most common side effects with omeprazole delayed-release capsules in adults and children include:

In addition to the side effects listed above, the most common side effects in children 1 to 16 years of age include:

Other side effects:

Serious allergic reactions. Tell your doctor if you get any of the following symptoms with omeprazole delayed-release capsules:

Your doctor may stop omeprazole delayed-release capsules if these symptoms happen.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects with omeprazole delayed-release capsules. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800FDA-1088.

How should I store omeprazole delayed-release capsules?

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

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

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

This Medication Guide summarizes the most important information about omeprazole delayed-release capsules. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

Please address medical inquiries to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

What are the ingredients in omeprazole delayed-release capsules?

Active ingredient in omeprazole delayed-release capsules: Omeprazole, USP

Inactive ingredients in omeprazole delayed-release capsules: Acetone, di-sodium hydrogen phosphate dihydrate, FD&C blue 1, gelatin, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, polyethylene glycol, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide and triethyl citrate.  Additionally each 10 mg and 40 mg capsule shell contains FD&C red 3 and FD&C green 3; each 20 mg capsule shell contains iron oxide red and iron oxide yellow. The capsule is printed with black pharmaceutical ink which contains following ingredients: black iron oxide, potassium hydroxide, propylene glycol and shellac.

*Brands mentioned are the trademarks of their respective owners.

Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

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

Revised: 2/2021
Zydus Pharmaceuticals (USA) Inc.