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Esomeprazole (esomeprazole 20 mg) Dailymed


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


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Drug Facts


Active ingredient (in each tablet)

Esomeprazole 20 mg

(Each delayed-release tablet corresponds to 22.3 mg

esomeprazole magnesium trihydrate) 

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

OTC - DO NOT USE SECTION

  • 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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
  • taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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

DOSAGE & ADMINISTRATION SECTION


14-Day Course of Treatment
  • take 1 tablet before eating in the morning
  • do not crush or chew tablets
  • place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water.
  • take every day for 14 days
  • do not take more than 1 tablet a day
  • do not use for more than 14 days unless directed by your doctor
  • do not take this medicine with alcohol

INFORMATION FOR PATIENTS SECTION

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 Safety Information


Other information

  • read the directions and warnings before use
  • keep the carton. It contains important information
  • store at 20-25°C (68-77°F); keep product out of high heat and moisture
  • store in the original package

Inactive Ingredients


acetone, alcohol, amino methacrylate copolymer, ascorbic acid, benzyl alcohol, cetyl alcohol, colloidal silicon dioxide, crospovidone, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, flavor, hypromellose, hypromellose phthalate, isopropyl alcohol, mannitol, microcrystalline cellulose, modified starch, polysorbate 80, pregelatinized starch, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triacetin, triethyl citrate

1-800-xxx-xxxx:


Weekdays XXX AM to XXX PM EST

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.

Package Label.principal Display Panel


NDC 64239-112-02

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR


Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size



Package Label.principal Display Panel


NDC 64239-112-03

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

28 TABLETS

Two 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size



Package Label.principal Display Panel


NDC 64239-112-04

MELTechTM

Melts in Your Mouth

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

42 TABLETS

Three 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size



Package Label.principal Display Panel


NDC 64239-112-05

MELTechTM

Melts in Your Mouth 

FREE SAMPLE

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

2 TABLETS

First 2 doses of a 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size



Package Label.principal Display Panel


NDC 64239-112-07

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

14 TABLETS

One 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size



Package Label.principal Display Panel


NDC 64239-112-08

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

28 TABLETS

Two 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size



Package Label.principal Display Panel


NDC 64239-112-09

MELTechTM

Melts in Your Mouth 

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

42 TABLETS

Three 14-day courses of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size



Package Label.principal Display Panel


NDC 64239-112-10

MELTechTM

Melts in Your Mouth 

FREE SAMPLE

Compare to the active ingredient in Nexium® 24HR*

Treats Frequent Heartburn! 24HR

Esomeprazole

Delayed Release

Orally Disintegrating Tablets 20 mg

Acid Reducer

Melts  in your mouth

Dissolves without water

2 TABLETS

First 2 doses of a 14-day course of treatment

May take 1 to 4 days for full effect

Wildberry Flavor

Actual size



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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