leader esomeprazole magnesium
Generic: ESOMEPRAZOLE
Basic Information
Manufacturer
Cardinal Health 110, LLC. dba Leader
Product Type
HUMAN OTC DRUG
Route of Administration
ORAL
FDA Set ID
c9472b82-d345-4531-bf07-bd55c94876ab
Purpose
Purpose Acid reducer
Indications & 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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
• 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.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).