OMEPRAZOLE- omeprazole capsule, delayed release 
Aphena Pharma Solutions - Tennessee, LLC

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MEDICATION GUIDE

Omeprazole Delayed-Release Capsules, USP

CIA77775D
Rev. 4E 03/2014

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?

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 is Omeprazole Delayed-Release Capsules?

Omeprazole Delayed-Release Capsules is a prescription medicine called a proton pump inhibitor (PPI). Omeprazole Delayed-Release Capsules reduces the amount of acid in your stomach.

Omeprazole Delayed-Release Capsules is used in adults:

For children 2 to 16 years of age, Omeprazole Delayed-Release Capsules is used:

It is not known if Omeprazole Delayed-Release Capsules is safe and effective for the treatment of gastroesophageal reflux disease (GERD) in children under 2 years of age.

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 you take Omeprazole Delayed-Release Capsules, tell your doctor if you:

Tell your doctor about all of the medicines you take including prescription and non-prescription drugs, anticancer drugs, vitamins and herbal supplements. Omeprazole Delayed-Release Capsules may affect how other medicines work, and other medicines may affect how Omeprazole Delayed-Release Capsules work.

Especially tell your doctor if you take:

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

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?

Take Omeprazole Delayed-Release Capsules exactly as prescribed by your doctor.

What are the possible side effects of Omeprazole Delayed-Release Capsules?

Omeprazole Delayed-Release Capsules can cause serious side effects, including:

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 2 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 do not go away. These are not all the possible side effects with Omeprazole 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 Omeprazole Delayed-Release Capsules?

Keep Omeprazole Delayed-Release Capsules and all medicines out of the reach of children.

General information about 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.

For more information, go to www.kremersurban.com or call 1-866-822-0068.

Instructions for Use

For instructions on taking Delayed-Release Capsules, please see "How should I take Omeprazole Delayed-Release Capsules?"

What are the ingredients in Omeprazole Delayed-Release Capsules?

Active ingredient in Omeprazole Delayed-Release Capsules: omeprazole

Inactive ingredients in Omeprazole Delayed-Release Capsules: (including the capsule shells): crospovidone, glyceryl behenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, silicon dioxide, talc, titanium dioxide and triethyl citrate. The capsule shells also contain gelatin and may contain sodium lauryl sulfate. In addition, the 20 mg and 40 mg capsule shells also contain yellow iron oxide. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, isopropyl alcohol, propylene glycol and shellac glaze. The ink may also contain dehydrated alcohol.

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

Revised: 04/2014
 
Aphena Pharma Solutions - Tennessee, LLC