LANSOPRAZOLE- lansoprazole capsule, delayed release 
American Health Packaging

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MEDICATION GUIDE

8411121/0323

Lansoprazole Delayed-Release Capsules, USP
(lan soe’ pra zole)

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

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

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

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

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

Lansoprazole delayed-release capsules can have other serious side effects. See “What are the possible side effects of lansoprazole delayed-release capsules?”

What are lansoprazole delayed-release capsules? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.

In adults, lansoprazole delayed-release capsules are used for:

Children:

Give lansoprazole delayed-release capsules exactly as prescribed by your child’s doctor. Do not increase the dose of lansoprazole delayed-release capsules or give your child lansoprazole delayed-release capsules longer than the amount of time your doctor tells you to.

In children 1 to 11 years of age, lansoprazole delayed-release capsules are used for:

In children 12 to 17 years of age, lansoprazole delayed-release capsules are used for:

Lansoprazole delayed-release capsules are not recommended for treating the symptoms of GERD in children less than 1 year of age and may harm them.

Do not take lansoprazole delayed-release capsules if you are:

Before you take lansoprazole delayed-release capsules, 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, REDITREX, XATMEP).

How should I take lansoprazole delayed-release capsules?

Lansoprazole Delayed-Release Capsules:

What are the possible side effects of lansoprazole delayed-release capsules?

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

Stop taking lansoprazole delayed-release capsules and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.

The most common side effects of lansoprazole delayed-release capsules include: diarrhea, stomach-area (abdomen) pain, nausea and constipation.

These are not all the possible side effects of lansoprazole 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 lansoprazole delayed-release capsules?
Store lansoprazole delayed-release capsules at room temperature between 20° to 25° C (68° to 77° F)

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

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

You can ask your doctor or pharmacist for information about lansoprazole delayed-release capsules that is written for healthcare professionals.

What are the ingredients in lansoprazole delayed-release capsules?

Active ingredient: lansoprazole.

Inactive ingredients in lansoprazole delayed-release capsules

Ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide.

Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.

All other trademark names are the property of their respective owners.

For more information about the drug product, call 1-888-375-3784.
For more information about the packaging or labeling, call American Health Packaging at 1-800-707-4621.

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

INSTRUCTIONS FOR USE

Lansoprazole Delayed-Release Capsules, USP
(lan soe’ pra zole)

Important:

Lansoprazole delayed-release capsules

Taking lansoprazole delayed-release capsules with certain food:

You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.

  1. Open the capsule.
  2. Sprinkle the granules on 1 tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
  3. Swallow right away.

Taking lansoprazole delayed-release capsules with certain juices:

You can only use apple juice, orange juice or tomato juice.

  1. Open the capsule.
  2. Sprinkle the granules into 60 mL (about ¼ cup) of apple juice, orange juice or tomato juice.
  3. Stir.
  4. Swallow right away.
  5. To make sure that the entire dose is taken, add 1/2 cup or more of juice to the glass and swallow right away.

Giving lansoprazole delayed-release capsules through a nasogastric tube (NG tube) 16 French or larger:

You can only use apple juice.

  1. Place 40 mL of apple juice into a clean container.
  2. Open the capsule and empty the granules into the container of apple juice.
  3. Use a catheter-tip syringe to draw up the apple juice and granule mixture.
  4. Gently mix the catheter-tip syringe to keep the granules from settling.
  5. Attach the catheter-tip syringe to the NG tube.
  6. Give the mixture right away through the NG tube that goes into the stomach. Do not save the apple juice and granule mixture for later use.
  7. Refill the catheter-tip syringe with 40mL of apple juice and mix gently. Flush the NG tube with apple juice.

How should I store lansoprazole delayed-release capsules?

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

This Instruction for Use has been approved by the U.S. Food and Drug Administration.

To reorder additional Medication Guides, please call American Health Packaging at 1-800-707-4621.

All other trademark names are the property of their respective owners.

Rx only

Distributed by:
American Health Packaging
Columbus, OH 43217

8411121/0323

Revised: 10/2023
American Health Packaging