Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM CARDINAL HEALTH 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
ANDA214473

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient (in each tablet) *Esomeprazole 20 mg (Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)
Inactive Ingredients
Inactive ingredients colloidal silicon dioxide crospovidone hydroxy propyl cellulose hypromellose low substituted hydroxy propyl cellulose magnesium carbonate magnesium oxide methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid polysorbate 80 and sodium lauryl sulfate) microcrystalline cellulose mono and di-glycerides polyethylene glycol polysorbate 80 red iron oxide sodium stearyl fumarate 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) Tips for Managing Heartburn Avoid foods or drinks that are more likely to cause heartburn such as rich spicy fatty and fried foods chocolate caffeine alcohol and even some acidic fruits and vegetables. Eat slowly and do not eat big meals. Do not eat late at night or just before bedtime. Do not lie flat or bend over soon after eating. Raise the head of your bed. Wear loose-fitting clothing around your stomach. If you are overweight lose weight. If you smoke quit smoking. DISTRIBUTED BY CARDINAL HEALTH DUBLIN OHIO 43017 www.myleader.com 1-800-200-6313 Made in India
Strengths
20 mg 21.75 mg
Quantities
14 tablets
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: oval Color: pink Imprint: K;12

Identifiers & Packaging

Container Type BOTTLE
UNII
36H71644EQ
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets Bottle) LEADER ™ NDC 70000-0695-1 24 Hour Esomeprazole Magnesium Delayed-Release Tablets, 20 mg* | Acid Reducer Treats Frequent Heartburn 14 TABLETS One 14-Day Course of Treatment (May take 1 to 4 days for full effect) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets Container Carton Label) LEADER ™ NDC 70000-0695-1 24 Hour Esomeprazole Magnesium Delayed-Release Tablets, 20 mg* Acid Reducer COMPARE TO NEXIUM ® 24 HR active ingredient** 100 % Money Back Guarantee Treats Frequent Heartburn May Take 1 to 4 Days for Full Effect 14 TABLETS One 14-Day Course of Treatment Actual Size SEE NEW WARNING INFORMATION PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets Bottle) LEADER ™ NDC 70000-0695-1 24 Hour Esomeprazole Magnesium Delayed-Release Tablets, 20 mg* | Acid Reducer Treats Frequent Heartburn 14 TABLETS One 14-Day Course of Treatment (May take 1 to 4 days for full effect) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets Container Carton Label) LEADER ™ NDC 70000-0695-1 24 Hour Esomeprazole Magnesium Delayed-Release Tablets, 20 mg* Acid Reducer COMPARE TO NEXIUM ® 24 HR active ingredient** 100 % Money Back Guarantee Treats Frequent Heartburn May Take 1 to 4 Days for Full Effect 14 TABLETS One 14-Day Course of Treatment Actual Size SEE NEW WARNING INFORMATION PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

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

Warnings & Precautions
Warnings Allergy alert: ■ Do not use if you are allergic to esomeprazole. ■ Esomeprazole may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If an allergic reaction occurs, stop use and seek medical help 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 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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