Esomeprazole Magnesium Delayed-Release Capsules, 20 mg, Esomeprazole Magnesium Delayed-Release 20 mg mini ESOMEPRAZOLE MAGNESIUM CAPSULES MARKSANS PHARMA LIMITED 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
ANDA217264

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each capsule) Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
Inactive Ingredients
Inactive ingredients Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg Inactive ingredients black iron oxide eudragit FD&C Blue 1 FD&C Red 3 ferric oxide yellow gelatin glyceryl monostearate hydroxypropyl cellulose hypromellose magnesium stearate polysorbate 80 potassium hydroxide shellac simethicone sodium lauryl sulfate sugar spheres talc titanium dioxide triethyl citrate. Esomeprazole Magnesium Delayed-Release Capsules 20 mg (Mini Capsules) Inactive ingredients black iron oxide corn starch D&C red 27 aluminum lake eudragit FD&C blue 1 FD&C red 3 ferric oxide yellow gelatin glyceryl monostearate hydroxypropyl cellulose hypromellose magnesium stearate polysorbate 80 potassium hydroxide shellac simethicone sodium lauryl sulfate sucrose talc titanium dioxide triethyl citrate
Strengths
20 mg 22.3 mg
Quantities
14 count
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: purple Imprint: 112

Identifiers & Packaging

Container Type BOTTLE
UPC
0325000112769 0325000075767
UNII
R6DXU4WAY9
Packaging

PRINCIPAL DISPLAY PANEL NDC: 25000-075-76 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg 14 count bottle label NDC: 25000-075-76 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg 14 count carton label NDC: 25000-112-76 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules) 14 count bottle label NDC: 25000-112-76 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules) 14 count carton label esomeprazole-dr-20mg-14s-bottle-label esomeprazole-dr-20mg-14s-ifc-label esomeprazole-dr-minis-20mg-14s-bottle-label esomeprazole-dr-minis-20mg-14s-carton-caps

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC: 25000-075-76 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg 14 count bottle label NDC: 25000-075-76 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg 14 count carton label NDC: 25000-112-76 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules) 14 count bottle label NDC: 25000-112-76 Esomeprazole Magnesium Delayed-Release Capsules USP 20 mg (Mini capsules) 14 count carton label esomeprazole-dr-20mg-14s-bottle-label esomeprazole-dr-20mg-14s-ifc-label esomeprazole-dr-minis-20mg-14s-bottle-label esomeprazole-dr-minis-20mg-14s-carton-caps

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 • Esomeprazole may cause severe skin reactions. Symptoms include: o skin reddening o blisters o rash If an allergic reaction occurs, stop use and seek medical attention right away.
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 (1-800-222-1222) right away.

Storage & Handling

Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20-25°C (68-77°F)


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