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Esomeprazole (esomeprazole (esomeprazole magnesium) capsule, delayed release) Dailymed

  1. Human OTC
  2. Proton Pump Inhibitor
  3. INNOVUS PHARMACEUTICALS, INC.

Generic: esomeprazole magnesium is used for the treatment of Duodenal Ulcer Esophagitis Gastroesophageal Reflux Heartburn Stomach Ulcer Zollinger-Ellison Syndrome Helicobacter Infections

Esomeprazole capsule, delayed release - (esomeprazole (esomeprazole magnesium) capsule, delayed release) image

IMPRINT: RG 50     SHAPE: capsule
    COLOR: pink

  1. FDA Adverse Reactions

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Drug Facts

Active Ingredient (in Each Capsule)


*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)

Purpose


Acid reducer

Use

  • •treats frequent heartburn (occurs 2 or more days a week)
  • •not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings


Allergy alert: Do not use if you are allergic to esomeprazole

Do not use if you have:
  • •trouble or pain swallowing food, vomiting with blood, or bloody or black stools
  • •heartburn with lightheadedness, sweating or dizziness
  • •chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
  • •frequent chest pain

These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have:

  • •had heartburn over 3 months. This may be a sign of a more serious condition.
  • •frequent wheezing, particularly with heartburn
  • •unexplained weight loss
  • •nausea or vomiting
  • •stomach pain

Ask A Doctor Or Pharmacist Before Use If You Are:

  • •taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop Use And Ask A Doctor If:

  • •your heartburn continues or worsens
  • •you need to take this product for more than 14 days
  • •you need to take more than 1 course of treatment every 4 months
  • •you get diarrhea
  • •you develop a rash or joint pain

If Pregnant Or Breast-feeding,


ask a health professional before use.

Keep Out Of Reach Of Children.


In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • •adults 18 years of age and older
  • •this product is to be used once a day (every 24 hours), every day for 14 days
  • •may take 1 to 4 days for full effect
  • • 14-Day Course of Treatment
  • •swallow 1 capsule with a glass of water before eating in the morning
  • •take every day for 14 days
  • •do not take more than 1 capsule a day
  • •swallow whole. Do not crush or chew capsules.
  • •do not use for more than 14 days unless directed by your doctor
  •   Repeated 14-Day Courses (if needed)
  • •you may repeat a 14-day course every 4 months
  • • do not take for more than 14 days or more often than every 4 months unless directed by a doctor
  • •children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Other Information

  • •read the directions and warnings before use.
  • •Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.]
  • •keep the carton. It contains important information.

Inactive Ingredients


FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, 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.

Questions?


Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.

TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing.

Tips for Managing Heartburn
  • •Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
  • •Eat slowly and do not eat big meals.
  • •Do not eat late at night or just before bedtime.
  • •Do not lie flat or bend over soon after eating.
  • •Raise the head of your bed.
  • •Wear loose-fitting clothing around your stomach.
  • •If you are overweight, lose weight.
  • •If you smoke, quit smoking.

Distributed by:Innovus Pharmaceuticals, IncEnglewood, CO 80112

Principal Display Panel - 42 Capsule Bottle Carton


COMPARE TO THE ACTIVE INGREDIENT OF Nexium® 24HR†

NDC 57483-900-42

EsomepraCareâ„¢Esomeprazole Magnesium Delayed-Release Capsules 20 MG* USP / ACID REDUCER

42 CAPSULES Three 14-day courses of treatment

3 x 14 Count Bottles Inside

Treats Frequent Heartburn May take 1 to 4 days for full effect

24 HR

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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