Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM CAMBER CONSUMER CARE 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.
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Route
ORAL
Applications
ANDA212507

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT (in each capsule) Esomeprazole 20 mg (*Each delayed-release capsule corresponds to 22.25 mg esomeprazole magnesium trihydrate USP).
Inactive Ingredients
INACTIVE INGREDIENTS Black iron oxide FD&C Blue No. 1 FD&C Blue No. 2 gelatin glyceryl monostearate hydroxy propyl cellulose hypromellose magnesium stearate methacrylic acid ethyl acrylate copolymer potassium hydroxide polysorbate 80 propylene glycol shellac simethicone sodium lauryl sulfate strong ammonia solution sugar spheres (contains sucrose and corn starch) talc titanium dioxide triethyl citrate.
Strengths
20 mg 22.25 mg
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: H;E4

Identifiers & Packaging

Container Type BOX
UPC
0369230320310
UNII
R6DXU4WAY9
Packaging

PRINCIPAL DISPLAY PANEL Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Hetero) Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Annora) esomeprazoleheterocarton esomeprazoleannoracarton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Hetero) Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg - Carton (Annora) esomeprazoleheterocarton esomeprazoleannoracarton

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.

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

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.


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