OMEPRAZOLE- omeprazole capsule, delayed release 
American Health Packaging

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MEDICATION GUIDE

8012801/0420

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

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 are omeprazole delayed-release capsules?
Omeprazole delayed-release capsules are 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 2 to 16 years of age, omeprazole delayed-release capsules are 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:

You may or may not have symptoms of low magnesium. Tell your doctor right away if you develop any of these symptoms:

  • seizures
  • jitteriness
  • spasms of the hands and feet
  • dizziness
  • jerking movements or shaking (tremors)
  • cramps or muscle aches
  • abnormal or fast heart beat
  • muscle weakness
  • spasm of the voice box

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:

  • headache
  • nausea
  • vomiting
  • stomach pain
  • diarrhea
  • gas

In addition to the side effects listed above, the most common side effects in children 2 to 16 years of age include:

  • respiratory system events
  • fever

Other side effects:

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

  • rash
  • face swelling
  • throat tightness
  • difficulty breathing

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 1-800-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 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.

What are the ingredients in omeprazole delayed-release capsules?
Active ingredient in Omeprazole Delayed-Release Capsules: omeprazole
Inactive ingredients in omeprazole delayed-release capsules: Crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate.
The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide.

For more information, call 1-888-375-3784.

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

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

Taking omeprazole delayed-release capsules with applesauce:

  1. Place 1 tablespoon of applesauce into a clean container.
  2. Carefully open the capsule and sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce.
  3. Swallow the applesauce and pellet mixture right away. Do not chew or crush the pellets. Do not store the applesauce and pellet mixture for later use.

For additional Medication Guides call American Health Packaging at 1-800-707-4621.

Distributed by:
American Health Packaging
Columbus, OH 43217

8012801/0420

Revised: 6/2021
American Health Packaging