Esomeprazole Magnesium Tablet, Delayed Release
FDA Label NDC 70000-0695

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Esomeprazole Magnesium (NDC 70000-0695). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use if you have:, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each tablet)


*Esomeprazole 20 mg
(Each film-coated delayed-release tablet 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:
■ Do not use if you are allergic to esomeprazole.
■ Esomeprazole may cause severe skin reactions.
   Symptoms may include:
   ■  skin reddening ■  blisters ■  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.


Otc - Keep Out Of Reach Of Children

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 tablet with a glass of water before eating in the morning
    • take every day for 14 days
    • do not take more than 1 tablet a day
    • swallow whole. Do not crush or chew tablets.
    • 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

colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, 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)

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
    CARDINAL HEALTH
    DUBLIN, OHIO 43017
    www.myleader.com
    1-800-200-6313

    Made in India    

Package Label-Principal Display Panel - 20 Mg (14 Tablets Bottle)

LEADER™

NDC 70000-0695-1
24 Hour

Esomeprazole
Magnesium
Delayed-Release Tablets, 20 mg*    |   Acid Reducer

Treats Frequent Heartburn
14 TABLETS
One 14-Day Course of Treatment (May take 1 to 4 days for full effect)


Package Label-principal Display Panel (20 mg (14 Tablets))

Package Label-principal Display Panel (20 mg (14 Tablets))


Package Label-Principal Display Panel - 20 Mg (14 Tablets Container Carton Label)

LEADER™

NDC 70000-0695-1
24 Hour

Esomeprazole
Magnesium
Delayed-Release Tablets, 20 mg*
Acid Reducer

COMPARE TO
NEXIUM® 24 HR
active ingredient**

100 % Money
Back Guarantee

Treats Frequent
Heartburn

May Take 1 to 4 Days
for Full Effect

14 TABLETS
One 14-Day Course
of Treatment                            Actual Size

SEE NEW WARNING INFORMATION


Package Label-principal Display Panel (20 mg (14 Tablets))

Package Label-principal Display Panel (20 mg (14 Tablets))

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