Esomeprazole
Esomeprazole is an FDA drug label for the active ingredient ESOMEPRAZOLE MAGNESIUM manufactured by VALU MERCHANDISERS COMPANY administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231103.
- Generic name
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- VALU MERCHANDISERS COMPANY
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 63941-999
- Application
- ANDA212866
- Label effective
- 20231103
Active ingredients
Indications & Usage
Use • 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
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 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not crush or chew capsules. • 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.
Contraindications
Not available.
Warnings
Warnings Allergy alert: ▪ Do not use if you are allergic to esomeprazole ▪ Esomeprazole may cause severe skin reactions. Symptoms 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
Adverse Reactions
Not available.