Acid Reducer ESOMEPRAZOLE MAGNESIUM H E B 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
Mfr: H E B FDA #20 OTC
FunFoxMeds bottle
Route
ORAL
Applications
ANDA212088

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium USP (trihydrate))
Inactive Ingredients
Inactive ingredients black iron oxide colloidal silicon dioxide crospovidone hydroxypropyl cellulose hypromellose low substituted hydroxypropyl cellulose magnesium stearate methacrylic acid - ethyl acrylate copolymer dispersion microcrystalline cellulose mono-and di-glycerides polyethylene glycol polysorbate 80 propylene glycol red iron oxide shellac glaze sodium lauryl sulfate sodium stearyl fumarate sugar spheres (corn starch and sucrose) talc titanium dioxide triethyl citrate and yellow iron oxide
Strengths
20 mg 22.25 mg
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: EL

Identifiers & Packaging

Container Type BOTTLE
UPC
0041220534777
UNII
R6DXU4WAY9
Packaging

Principal Display Panel Compare to Nexium® 24 HR active ingredient** See New Warning Information Heartburn Relief 24 Hour Esomeprazole Magnesium Delayed-Release Tablets, 20 mg* Acid Reducer Treats Frequent Heartburn May Take 1 to 4 days for Full Effect TABLETS **This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Nexium® 24HR. TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP IS BROKEN OR MISSING. KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. MADE WITH PRIDE AND CARE FOR H-E-B® SAN ANTONIO, TX 78204; Package label H-E-B Acid Reducer Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP (trihydrate))

Package Descriptions
  • Principal Display Panel Compare to Nexium® 24 HR active ingredient** See New Warning Information Heartburn Relief 24 Hour Esomeprazole Magnesium Delayed-Release Tablets, 20 mg* Acid Reducer Treats Frequent Heartburn May Take 1 to 4 days for Full Effect TABLETS **This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Nexium® 24HR. TAMPER EVIDENT: DO NOT USE IF SEAL UNDER BOTTLE CAP IS BROKEN OR MISSING. KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. MADE WITH PRIDE AND CARE FOR H-E-B® SAN ANTONIO, TX 78204
  • Package label H-E-B Acid Reducer Esomeprazole 20 mg (*Each delayed-release tablet corresponds to 22.25 mg esomeprazole magnesium, USP (trihydrate))

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 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • swallow whole. Do not crush or chew tablets. • 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
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.

Questions

Questions or comments? Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST


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