esomeprazole ESOMEPRAZOLE THE KROGER COMPANY FDA Approved 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
FunFoxMeds bottle
Route
ORAL
Applications
ANDA212866

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) *Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)
Inactive Ingredients
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.
Strengths
20 mg 22.3 mg
Quantities
24 capsule 28 capsules
Treats Conditions
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
Pill Appearance
Shape: capsule Color: pink Imprint: RG50

Identifiers & Packaging

Container Type BOTTLE
UPC
0041260009938
UNII
R6DXU4WAY9
Packaging

PRINCIPAL DISPLAY PANEL - 24 Capsule Bottle Carton COMPARE TO the active ingredient of NEXIUM ® 24HR **See bottom panel NDC 30142-989-28 Kroger ® Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg* ACID REDUCER actual size OUR PHARMACIST RECOMMENDED Treats Frequent Heartburn! 24 HR 28 CAPSULES Two 14-Day Courses of Treatment May Take 1 to 4 Days for Full Effect PRINCIPAL DISPLAY PANEL - 24 Capsule Bottle Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 24 Capsule Bottle Carton COMPARE TO the active ingredient of NEXIUM ® 24HR **See bottom panel NDC 30142-989-28 Kroger ® Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg* ACID REDUCER actual size OUR PHARMACIST RECOMMENDED Treats Frequent Heartburn! 24 HR 28 CAPSULES Two 14-Day Courses of Treatment May Take 1 to 4 Days for Full Effect PRINCIPAL DISPLAY PANEL - 24 Capsule Bottle Carton

Overview

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

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

Dosage & Administration

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 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 swallow whole. Do not crush or chew capsules. 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 children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Warnings & Precautions
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 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 ) .
Purpose

Purpose Acid reducer

Do Not Use

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.

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

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 ) .

Storage & Handling

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.

Questions

Questions? 1-800-632-6900


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