Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM GUARDIAN DRUG COMPANY FDA Approved USE(S) 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
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Route
ORAL
Applications
ANDA216149
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT(in each capsule) *Esomeprazole 20 mg (Each delayed-release capsule corresponds to 22.3 mg esomeprazole magnesium trihydrate)
Inactive Ingredients
INACTIVE INGREDIENT SECTION FD&C blue 1 FD&C red 3 FD&C red 40 ferroso ferric oxide gelatin hydroxypropyl cellulose hypromellose magnesium stearate methacrylic acid and ethyl acrylate copolymer dispersion mono and di-glycerides polysorbate 80 potassium hydroxide shellac sodium lauryl sulfate sugar spheres (contains corn starch sucrose) talc titanium dioxide triethyl citrate
Strengths
20 mg 22.3 mg
Quantities
14 capsules
Treats Conditions
Use S 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: G666

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
R6DXU4WAY9
Packaging

PRINCIPAL DISPLAY PANEL NDC 53041-666-07 See new warning information Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg* Acid Reducer Treats Frequent Heartburn 24 HR Capsules May take 1 to 4 days for full effect 14 CAPSULES - One 14-day course of treatment 666-GDC-14 666-GDC-14

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC 53041-666-07 See new warning information Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg* Acid Reducer Treats Frequent Heartburn 24 HR Capsules May take 1 to 4 days for full effect 14 CAPSULES - One 14-day course of treatment 666-GDC-14 666-GDC-14

Overview

USE(S) 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(S) 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 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 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.

Storage & Handling

OTHER INFORMATION read the directions and warnings before use keep the carton. It contains important information. store at 20-25ºC (68-77ºF)


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