Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM AHOLD U.S.A., INC, 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
ANDA209339

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each capsule) *Esomeprazole 20 mg (Each delayed-release capsule corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide FD&C blue no.1 gelatin hydroxypropyl cellulose hypromellose magnesium carbonate magnesium oxide methacrylic acid copolymer dispersion mono and di glycerides polysorbate 80 propylene glycol shellac sodium lauryl sulfate strong ammonia solution sugar spheres (which contains liquid glucose starch (maize) and sucrose) talc titanium dioxide triethyl citrate and yellow iron oxide. Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) DISTRIBUTED BY: FOODHOLD U.S.A. LLC LANDOVER MD 20785 Product of India Code: TS/DRUGS/22/2009 1-877-846-9949 ©2019 Ahold Licensing Delhaize Quality guaranteed or your money back.
Strengths
20 mg 21.75 mg
Quantities
14 capsule 14 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: white Imprint: I81

Identifiers & Packaging

Container Type BOTTLE
UNII
36H71644EQ
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label) CAREone® NDC 60000-109-05 ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP 20 mg* Acid Reducer 24 HR Treats Frequent Heartburn May take 1 to 4 days for full effect 14 Capsules One 14-day course of treatment PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton) CAREone® NDC 60000-109-05 #Compare to the active ingredient in Nexium ® 24 HR See new warning ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP 20 mg* Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect Capsules 24hr 14 Capsules One 14-day Course of treatment PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label) CAREone® NDC 60000-109-05 ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP 20 mg* Acid Reducer 24 HR Treats Frequent Heartburn May take 1 to 4 days for full effect 14 Capsules One 14-day course of treatment PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Label)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container Carton) CAREone® NDC 60000-109-05 #Compare to the active ingredient in Nexium ® 24 HR See new warning ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP 20 mg* Acid Reducer Treats Frequent Heartburn May take 1 to 4 days for full effect Capsules 24hr 14 Capsules One 14-day Course of treatment PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Capsule Container 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. Other information read the directions and warnings before use keep the carton. It contains important information. store at 20-25°C (68-77°F) Meets USP dissolution test 2

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 If pregnant or breast-feeding, ask a health professional before use.

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)


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