FDA Label for Esomeprazole Magnesium
View Indications, Usage & Precautions
Esomeprazole Magnesium Product Label
The following document was submitted to the FDA by the labeler of this product Little Pharma, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Capsule)
*Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)
Purpose
Acid reducer
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
Allergy alert: Do not use if you are allergic to esomeprazole
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• 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
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have:
Ask Doctor/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).
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• 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• 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.
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
Other Information
• read the directions and warnings before use• Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room temperature.]• keep the carton. It contains important information.• TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing.
Questions
Call toll-free weekdays 8:30 AM to 5 PM EST at 1-800-818-4555.
Inactive Ingredients
FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.
Distributed by:
Little Pharma Inc.
New York, NY 10023
Package/Label Principal Display Panel
Curist
Heartburn Relief
Esomeprazole Magnesium Delayed-Release Capsules
USP, 20 mg* / Acid Reducer
24
HR
Treats Frequent Heartburn
May take 1 to 4 days for full effect
42 CAPSULES
Three 14-day courses of treatment
May take 1 to 4 days for full effect
* Please review the disclaimer below.