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  5. Label Information: Nexium 24hr

FDA Label for Nexium 24hr

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. ALLERGY ALERT
    6. DO NOT USE IF YOU HAVE:
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DOSAGE & ADMINISTRATION
    13. STORAGE AND HANDLING
    14. INACTIVE INGREDIENT
    15. OTC - QUESTIONS
    16. ADDITIONAL INFORMATION
    17. PRINCIPAL DISPLAY PANEL

Nexium 24hr Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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