Omeprazole delayed release OMEPRAZOLE TIME CAP LABORATORIES, 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
ANDA218829

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Omeprazole USP 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Inactive Ingredients
Inactive ingredients colloidal silicone dioxide crospovidone glyceryl monostearate hydroxypropyl cellulose hypromellose magnesium stearate methacrylic acid and ethyl acrylate copolymer microcrystalline cellulose polyethylene glycol 400 polyethylene glycol 6000 polysorbate 80 red iron oxide simethicone sodium stearyl fumarate starch sucrose talc titanium dioxide triethyl citrate
Strengths
20 mg 20.6 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: oval Color: pink Imprint: 91

Identifiers & Packaging

Container Type UNKNOWN
UPC
0349483731415
UNII
426QFE7XLK
Packaging

731R Omezprazole 20mg Tablets IFC 731R Omeprazole 20mg Tablets Label 731R IFC 731R label

Package Descriptions
  • 731R Omezprazole 20mg Tablets IFC 731R Omeprazole 20mg Tablets Label 731R IFC 731R label

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 for adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 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 - do not use for more than 14 days unless directed by your doctor - swallow whole. Do not chew or crush tablets. 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. Heartburn in children may sometimes be caused by a serious condition.

Warnings & Precautions
Warnings Allergy alert: Do not use if you are allergic to Omeprazole Omeprazole may cause severe skin reactions. Symptoms may include: - skin reddening - blisters - rash If an allergic reaction occurs, stop use and seek medical attention 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 (1-800-222-1222) right away.

Questions

Questions or comments? Call 1-877-290-4008


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