PANTOPRAZOLE SODIUM- pantoprazole sodium tablet, delayed release 
AvKARE, Inc.

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MEDICATION GUIDE

Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um) Delayed-Release Tablets USP

What is the most important information I should know about pantoprazole sodium delayed-release tablets?

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

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

Pantoprazole sodium delayed-release tablets can cause serious side effects, including:

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

Pantoprazole sodium delayed-release tablets can have other serious side effects. See “What are the possible side effects of pantoprazole sodium delayed-release tablets?”

What are pantoprazole sodium delayed-release tablets?

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

In adults, pantoprazole sodium delayed-release tablets are used for:

In children 5 years of age and older, pantoprazole sodium delayed-release tablets are used for:

It is not known if pantoprazole sodium delayed-release tablets are safe if used longer than 8 weeks in children. Pantoprazole sodium delayed-release tablets are not for use in children under 5 years of age.

It is not known if pantoprazole sodium delayed-release tablets are safe and effective in children for treatment other than EE.

Do not take pantoprazole sodium delayed-release tablets if you are:

Before taking pantoprazole sodium delayed-release tablets, tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).

How should I take pantoprazole sodium delayed-release tablets?

Take pantoprazole sodium delayed-release tablets exactly as prescribed by your doctor.

What are the possible side effects of pantoprazole sodium delayed-release tablets?

Pantoprazole sodium delayed-release tablets can cause serious side effects, including:

The most common side effects of pantoprazole sodium delayed-release tablets in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain.

The most common side effects of pantoprazole sodium delayed-release tablets in children include: upper respiratory infection, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain.

These are not all the possible side effects of pantoprazole sodium delayed-release tablets. 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 pantoprazole sodium delayed-release tablets?

Store pantoprazole sodium delayed-release tablets at room temperature between 68° to 77°F (20° to 25°C).

Keep pantoprazole sodium delayed-release tablets and all medicines out of the reach of children.

General information about pantoprazole sodium delayed-release tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pantoprazole sodium delayed-release tablets for a condition for which they were not prescribed. Do not give pantoprazole sodium delayed-release tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your doctor or pharmacist for information about pantoprazole sodium delayed-release tablets that is written for health professionals.

What are the ingredients in pantoprazole sodium delayed-release tablets USP?

Active ingredient: pantoprazole sodium sesquihydrate

Inactive ingredients in pantoprazole sodium delayed-release tablets: calcium carbonate, calcium stearate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, iron oxide yellow, lactose monohydrate, low-substituted hydroxypropyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, propylene glycol, shellac glaze, sodium carbonate anhydrous, stearic acid, talc, titanium dioxide, and triethyl citrate.

For more information call 1-888-838-2872.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Rev. 12/17
AV Rev. 02/18 (P)

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

Revised: 2/2020
AvKARE, Inc.