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Esomeprazole Magnesium (esomeprazole magnesium capsule, delayed release) Dailymed

  1. Human OTC
  2. Proton Pump Inhibitor
  3. Camber Consumer Care Inc

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

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

IMPRINT: H E4     SHAPE: capsule
    COLOR: blue

  1. FDA Adverse Reactions

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Active Ingredient (in Each Capsule)


Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).

Purpose


Acid reducer

Uses

  •  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.
  • Esomeprazole may cause severe skin reactions. Symptoms may include:
  •  skin reddening .  bulers  . rash If an allergic reaction occurs, stop use and seek medical help right away.

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 Adoctor 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.

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 before use. Heartburn in children may sometimes be caused by a serious condition.

Other Information

  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)

Inactive Ingredients


Black iron oxide, FD&C Blue No. 1, FD&C Blue No. 2, gelatin, glyceryl monostearate, hydroxy propyl cellulose, hypromellose, magnesium stearate, methacrylic acid ethyl acrylate copolymer, potassium hydroxide, polysorbate 80, propylene glycol, shellac, simethicone, sodium lauryl sulfate, strong ammonia solution, sugar spheres (contains sucrose and corn starch), talc, titanium dioxide, triethyl citrate.

Questions Or Comments?


call toll-free weekdays 9 AM to 5 PM EST at 1-888-588-1418.

Distributed by: Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

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Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton

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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