esomeprazole magnesium capsule, delayed release

FDA Drug Profile — Esomeprazole Magnesium

Drug Details

Generic Name
esomeprazole magnesium capsule, delayed release
Brand Names
Esomeprazole Magnesium
Application Number
ANDA212507
Sponsor
Allegiant Health
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
ESOMEPRAZOLE MAGNESIUM

Indications and Usage

Use(s) 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 Esomeprazole may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use 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 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 If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.