Esomeprazole

ESOMEPRAZOLE MAGNESIUM ORAL HUMAN OTC DRUG

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

Active ingredient (in each capsule) † Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)

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.

More products with the same ingredient

ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM

Reliable 1 Laboratories LLC View label

Esomeprazole Magnesium

A-S Medication Solutions View label

Esomeprazole Magnesium

Mylan Pharmaceuticals Inc. View label

Esomeprazole Magnesium

Proficient Rx LP View label

Esomeprazole Magnesium

A-S Medication Solutions View label

Esomeprazole Magnesium

A-S Medication Solutions View label

Esomeprazole Magnesium

Proficient Rx LP View label