Esomeprazole ESOMEPRAZOLE MAGNESIUM OHM LABORATORIES INC. 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

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 42 capsules 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
UNII
R6DXU4WAY9
Packaging

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton † Compare To the active ingredient of Nexium ® 24HR See new warning information NDC 51660-027-44 Treats Frequent Heartburn 24 HR Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg* / Acid Reducer May take 1 to 4 days for full effect ohm ® 42 CAPSULES Three 14-day courses of treatment 3 x 14 Count Bottles Inside 42ct-carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton † Compare To the active ingredient of Nexium ® 24HR See new warning information NDC 51660-027-44 Treats Frequent Heartburn 24 HR Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg* / Acid Reducer May take 1 to 4 days for full effect ohm ® 42 CAPSULES Three 14-day courses of treatment 3 x 14 Count Bottles Inside 42ct-carton

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 8:30 AM to 5 PM EST at 1-800-818-4555. 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: Ohm Laboratories Inc. New Brunswick, NJ 08901 R0922


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