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  5. Label Information: Esomeprazole

FDA Label for Esomeprazole

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. INACTIVE INGREDIENTS
    7. QUESTIONS OR COMMENTS? 1-800-XXX-XXXX:
    8. TIPS FOR MANAGING HEARTBURN

Esomeprazole Product Label

The following document was submitted to the FDA by the labeler of this product Dexcel Pharma Technologies Ltd. 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.

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


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

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


Questions Or Comments? 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.

* Please review the disclaimer below.