ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release 
NuCare Pharmaceuticals,Inc.

----------

MEDICATION GUIDE

Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um) Delayed-Release Capsules, USP

Rx only

Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules, USP before you start taking esomeprazole magnesium delayed-release capsules, USP 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 esomeprazole magnesium delayed-release capsules, USP?

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

Esomeprazole magnesium delayed-release capsules, USP can cause serious side effects, including:

What are esomeprazole magnesium delayed-release capsules, USP?

Esomeprazole magnesium delayed-release capsules, USP are a prescription medicine called a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules, USP reduces the amount of acid in your stomach.

Esomeprazole magnesium delayed-release capsules, USP are used in adults:

For children and adolescents 1 year to 17 years of age, esomeprazole magnesium delayed-release capsules, USP may be prescribed for up to 8 weeks for short-term treatment of GERD.

Who should not take esomeprazole magnesium delayed-release capsules, USP?

Do not take esomeprazole magnesium delayed-release capsules, USP if you:

What should I tell my doctor before taking esomeprazole magnesium delayed-release capsules, USP?

Before you take esomeprazole magnesium delayed-release capsules, USP, tell your doctor if you:

Tell your doctor about all of the medicines you take, including prescription and non-prescription drugs, vitamins and herbal supplements. Esomeprazole magnesium delayed-release capsules, USP may affect how other medicines work, and other medicines may affect how esomeprazole magnesium delayed-release capsules, USP work.

Especially tell your doctor if you take:

  • warfarin (Coumadin, Jantoven)
  • Rifampin (Rimactane, Rifater, Rifamate)
  • ketoconazole (Nizoral)
  • cilostazol (Pletal)
  • voriconazole (Vfend)
  • diazepam (Valium)
  • atazanavir (Reyataz)
  • tacrolimus (Prograf)
  • nelfinavir (Viracept)
  • erlotinib (Tarceva)
  • saquinavir (Fortovase)
  • methotrexate
  • products that contain iron
  • clopidogrel (Plavix)
  • digoxin (Lanoxin)
  • mycophenolate mofetil (Cellcept)
  • St. John's Wort ( Hypericum perforatum)

How should I take esomeprazole magnesium delayed-release capsules, USP?

What are the possible side effects of esomeprazole magnesium delayed-release capsules, USP?

Esomeprazole magnesium delayed-release capsules, USP can cause serious side effects, including:

You may or may not have symptoms of low magnesium.

Tell your doctor right away if you have any of these symptoms:

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

Your doctor may check the level of magnesium in your body before you start taking esomeprazole magnesium delayed-release capsules, USP or during treatment if you will be taking esomeprazole magnesium delayed-release capsules, USP for a long period of time.

The most common side effects with esomeprazole magnesium delayed-release capsules, USP may include:

  • headache
  • abdominal pain
  • diarrhea
  • constipation
  • nausea
  • dry mouth
  • gas
  • drowsiness

Other side effects:

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

  • rash
  • throat tightness
  • face swelling
  • difficulty breathing

Your doctor may stop esomeprazole magnesium delayed-release capsules, USP if these symptoms happen.

Tell your doctor if you have any side effects that bother you or that do not go away. These are not all the possible side effects with esomeprazole magnesium delayed-release capsules, USP.

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 esomeprazole magnesium delayed-release capsules, USP?

Keep esomeprazole magnesium delayed-release capsules, USP and all medicines out of the reach of children.

General information about esomeprazole magnesium delayed-release capsules, USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use esomeprazole magnesium delayed-release capsules, USP for a condition for which it was not prescribed. Do not give esomeprazole magnesium delayed-release capsules, USP 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 esomeprazole magnesium delayed-release capsules, USP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about esomeprazole magnesium delayed-release capsules, USP that is written for health professionals.

For more information, call 1-800-818-4555.

What are the ingredients in esomeprazole magnesium delayed-release capsules, USP?

Active ingredient: esomeprazole magnesium (anhydrous)

Inactive ingredients in esomeprazole magnesium delayed-release capsules (including the capsule shells): D&C Red #28, FD&C Blue #1, FD&C Red #40, ferric oxide black, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide, and triethyl citrate.

Instructions for Use

For instructions on taking Delayed-Release Capsules, see the section of this leaflet called " How should I take esomeprazole magnesium delayed-release capsules, USP?"

Esomeprazole magnesium delayed-release capsules, USP may be given through a nasogastric tube (NG tube), as prescribed by your doctor. Follow the instructions below:

Esomeprazole magnesium delayed-release capsules, USP:

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

All trademarks are the property of their respective owners.

Manufactured by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512

  1. June 2018 FDA-04
Revised: 7/2024
NuCare Pharmaceuticals,Inc.