Esomeprazole ESOMEPRAZOLE MAGNESIUM YYBA CORP FDA Approved Use 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
Package NDC

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
42 capsule 14 count
Treats Conditions
Use 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: RG;50

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
R6DXU4WAY9
Packaging

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton welmate ® NDC 73581-013-42 HEARTBURN RELIEF ACID REDUCER Esomeprazole Magnesium USP, 20 mg* ✓Treats Frequent Heartburn ✓May Take 1 to 4 Days for Full Effect 24 HOUR 42 DELAYED-RELEASE CAPSULES 3 X 14 Count Bottles Inside Three 14-day courses of treatment RECOMMENDED BY HEALTHCARE PROFESSIONALS welmate-Esomeprazole-42s

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton welmate ® NDC 73581-013-42 HEARTBURN RELIEF ACID REDUCER Esomeprazole Magnesium USP, 20 mg* ✓Treats Frequent Heartburn ✓May Take 1 to 4 Days for Full Effect 24 HOUR 42 DELAYED-RELEASE CAPSULES 3 X 14 Count Bottles Inside Three 14-day courses of treatment RECOMMENDED BY HEALTHCARE PROFESSIONALS welmate-Esomeprazole-42s

Overview

Use 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

Use 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: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away. 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
Purpose

Purpose Acid reducer

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).

Questions

Questions? Call toll-free weekdays 9 AM to 6 PM EST at 866-933-6337. TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing. 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: Wellspring Airmont, NY 10952, U.S.A. R0922


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