Nexium 24hr Tablet
FDA Label NDC 0573-2451

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Nexium 24hr (NDC 0573-2451). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, allergy alert, do not use if you have:, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient (in each tablet)

Esomeprazole 20 mg (Each delayed-release tablet corresponds to 22.3 mg esomeprazole magnesium trihydrate)

Otc - Purpose

Purpose

Acid reducer

Indications & Usage

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

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

Otc - Ask Doctor/Pharmacist

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

Otc - Pregnancy Or Breast Feeding

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.

Dosage & Administration

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.

Storage And Handling

Other Information

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

Inactive Ingredient

Inactive ingredients

corn starch, crospovidone, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer, mica, microcrystalline cellulose, paraffin, polyethylene glycol, polysorbate 80, sodium stearyl fumarate, sucrose, talc, titanium dioxide, triethyl citrate

Otc - Questions

Questions or comments?

call toll-free weekdays 9 AM to 5 PM EST at 1-866-226-1600

Made in France

For most recent product information, visit
www.Nexium24HR.com

Nexium is a registered trademark of AstraZeneca AB and is used under license.

Do Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or

missing.

Additional Information

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

Principal Display Panel

NDC 0573-2451-42

Nexium®

esomeprazole magnesium

delayed-release tablets

20 mg/acid reducer

24HR

See new warning information

Treats Frequent Heartburn

Tablets

May take 1 to 4 days for full effect

42 TABLETS

Three 14-day courses of treatment

PAA114854 Front Carton

Nexium 24 Hr Tablets  42ct (Image 01)

Nexium 24 Hr Tablets 42ct (Image 01)

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