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Esomeprazole Magnesium Dailymed

  1. Human OTC
  2. Proton Pump Inhibitor
  3. Aurohealth LLC

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 - image

  1. FDA Adverse Reactions

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Drug Facts


Active ingredient   (in each capsule)  

*Esomeprazole 20 mg(Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate 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: â–  Do not use if you are allergic to esomeprazole. â–  Esomeprazole may cause severe skin reactions. Symptoms may include: â–  Skin reddening â–  bulers â–  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 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 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 20-25°C (68-77°F)
  • Meets USP dissolution test 2

Inactive Ingredients


colloidal silicon dioxide, FD&C blue no.1, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion, mono and di glycerides, polysorbate 80, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, sugar spheres (which contains liquid glucose, starch (maize) and sucrose), talc, titanium dioxide, triethyl citrate and yellow iron oxide. Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

Distributed by:   AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/22/2009

Package Label-principal Display Panel - 20 Mg (14 Capsule Container Label)


AUROHEALTH NDC 58602-809-05 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg* Acid Reducer 24 HR May take 1 to 4 days for full effect Treats Frequent Heartburn 14 Capsules One 14-day course of treatment

Package Label-principal Display Panel - 20 Mg (14 Capsule Container Carton)


#Compare to Nexium® 24 HR Active ingredient AUROHEALTH NDC 58602-809-05 See new warning information Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg* Acid Reducer 24 HR Treats Frequent Heartburn

May take 1 to 4 days for full effect 14 Capsules One 14-day Course of treatment        

Package Label-principal Display Panel - 20 Mg (28 Capsule Container Carton)


AUROHEALTH NDC 58602-809-61 #Compare to Nexium® 24 HR Active ingredient See new warning information Esomeprazole Magnesium D elayed-Release Capsules USP 20 mg* Acid Reducer 24 HR Treats Frequent Heartburn May take 1 to 4 days for full effect 28 Capsules (2 bottles of 14 each) Two 14-day courses of treatment

Package Label-principal Display Panel - 20 Mg (14 Capsule Container Carton)


AUROHEALTH NDC 58602-809-05 #Compare to Nexium® 24 HR Active ingredient See new warning information Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg* Acid Reducer 24 HR Treats Frequent Heartburn

May take 1 to 4 days for full effect 14 Capsules One 14-day Course of treatment

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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