esomeprazole magnesium dihydrate

FDA Drug Profile — esomeprazole magnesium, equate esomeprazole magnesium, Esomeprazole Magnesium, ESOMEPRAZOLE MAGNESIUM MINIS

esomeprazole magnesium dihydrate is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand names including esomeprazole magnesium, equate esomeprazole magnesium, Esomeprazole Magnesium. Available dosage forms: capsule, delayed release, powder.

Drug Details

Generic Name
esomeprazole magnesium dihydrate
Brand Names
esomeprazole magnesium, equate esomeprazole magnesium, Esomeprazole Magnesium, ESOMEPRAZOLE MAGNESIUM MINIS
Application Number
ANDA207193
Sponsor
Amazon.com Services LLC
NDC Codes
6
Dosage Forms
CAPSULE, DELAYED RELEASE, POWDER
Routes
ORAL
Active Ingredients
ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM

Indications and 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. • 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 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 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 breast-feeding, ask a health professional before use. Keep out of reach of children.