FDA Label for Esomeprazole
View Indications, Usage & Precautions
Esomeprazole Product Label
The following document was submitted to the FDA by the labeler of this product The Kroger Company. 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 moredays 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
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▪ 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 joint or rash 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
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▪ swallow whole. Do not crush or chew capsules.• children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
■ this product is to be used once a day (every 24 hours), every day for 14 days
■ it 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
■ 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
Other Information
▪ read the directions and warnings before use▪ Store at 20°C to 25°C (68°F to 7°F). [See USP Controlled Room Temperature].▪ keep the carton. It contains important information.
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 diglycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate
Package/Label Principal Display Panel
NDC 30142-989-28
Compare To the active ingredient of NEXIUM® 24HR **See side panel
Treats Frequent Heartburn!
Kroger
Esomeprazole Magnesium
Delayed-release Capsules USP, 20 mg*
ACID REDUCER
24HR
28 CAPSULES
Two 14-DAY courses of treatment
May take 1 to 4 days for full effect
* Please review the disclaimer below.