OMEPRAZOLE SODIUM BICARBONATE  - omeprazole sodium bicarbonate capsule 
Akron Pharma Inc

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SPL MEDGUIDE

                                        Omeprazole and Sodium Bicarbonate Capsules

                                           oh-ME-pray-zol/SO-dee-um by-KAR-boe-nate

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

What is the most important information I should know about Omeprazole and Sodium Bicarbonate Capsules?

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

Omeprazole and sodium bicarbonate capsules can cause serious side effects, including:

Omeprazole and sodium bicarbonate capsules can have other serious side effects. See "What are the possible side effects of Omeprazole and Sodium Bicarbonate Capsules?"

What is Omeprazole and Sodium Bicarbonate Capsules?

Omeprazole and sodium bicarbonate capsules is a prescription medicine called a proton pump inhibitor (PPI). Omeprazole and sodium bicarbonate capsules reduces the amount of acid in your stomach.

Omeprazole and sodium bicarbonate capsules are used in adults:

It is not known if omeprazole and sodium bicarbonate is safe and effective in children less than 18 years of age.

Who should not take Omeprazole and Sodium Bicarbonate Capsules?

Do not take omeprazole and sodium bicarbonate capsules if you:

What should I tell my doctor before I take Omeprazole and Sodium Bicarbonate Capsules?

Before you take omeprazole and sodium bicarbonate capsules, tell your doctor if you:

         have been told that you have low magnesium, calcium, or potassium levels in your blood

         have liver problems

         have heart failure

         have Bartter's syndrome (a rare kidney disorder)

         have any allergies

         have any other medical conditions

         are pregnant or plan to become pregnant. It is not known if omeprazole and sodium bicarbonate can harm your unborn baby.

Tell your doctor about all the medicines you take, including prescription and non-prescription drugs, anti-cancer drugs,  vitamins and herbal supplements. Omeprazole and sodium bicarbonate capsules may affect how other medicines work, and other medicines may affect how omeprazole and sodium bicarbonate capsules works.

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 and Sodium Bicarbonate Capsules?

What are the possible side effects of Omeprazole and Sodium Bicarbonate Capsules?

Omeprazole and sodium bicarbonate capsules may cause serious side effects, including:

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

The most common side effects with omeprazole and sodium bicarbonate include

Your doctor may stop omeprazole and sodium bicarbonate capsules if these symptoms happen.

Using omeprazole and sodium bicarbonate capsules for a long time may cause problems such as swelling and weight gain. Tell your doctor if this happens.

If you are on a low-sodium diet or at risk of developing congestive heart failure (CHF), you and your doctor should decide if you will take omeprazole and sodium bicarbonate capsules.

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 of omeprazole and sodium bicarbonate 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 and Sodium Bicarbonate Capsules?

Keep omeprazole and sodium bicarbonate capsules and all medicines out of the reach of children.

General information about Omeprazole and Sodium Bicarbonate Capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use omeprazole and sodium bicarbonate capsules for any condition for which it was not prescribed by your doctor. Do not give omeprazole and sodium bicarbonate capsules to other people, even if they have the same symptoms as you. It may harm them.

This Medication Guide summarizes the most important information about omeprazole and sodium bicarbonate capsules. If you would like more information, talk to your doctor. You can also ask your doctor or pharmacist for information about omeprazole and sodium bicarbonate that is written for healthcare professionals.

For more information, call 1-866-604-3268.

What are the ingredients in Omeprazole and Sodium Bicarbonate Capsules?

Active ingredients: omeprazole, USP

Inactive ingredients of omeprazole and sodium bicarbonate capsules: sodium bicarbonate, croscarmellose sodium and sodium stearyl fumarate. The capsules consist of gelatin and titanium dioxide. In addition the 20 mg/1100 mg capsule shell contains sodium lauryl sulfate and the 40 mg/1100 mg capsule shell contains FD&C Blue 1. The capsules are printed with edible ink containing  black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution.

Instructions for Use

For instructions on taking omeprazole and sodium bicarbonate capsules by mouth, see "How should I take Omeprazole and Sodium Bicarbonate Capsules?"

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

Manufactured for:

Akron Pharma, Inc.,

Fairfield, NJ 07004

Rev: 05/17

Revised: 7/2017
Akron Pharma Inc