Omeprazole OMEPRAZOLE PLD ACQUISITIONS LLC DBA AVMA PHARMA SOLUTIONS 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
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Route
ORAL
Applications
ANDA206582

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Inactive Ingredients
Inactive ingredients acetyl tributyl citrate colloidal silicon dioxide corn starch croscarmellose sodium hydroxypropyl cellulose hypromellose 2910 magnesium stearate methacrylic acid copolymer type C microcrystalline cellulose polyethylene glycol 400 polyethylene glycol 3350 polyethylene glycol 8000 polyvinyl alcohol sucrose talc titanium dioxide triethyl citrate
Strengths
20 mg 20.6 mg
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: oval Color: red Imprint: O

Identifiers & Packaging

Container Type BOX
UNII
426QFE7XLK
Packaging

Principal display panel †Compare to the active ingredient in Prilosec® OTC 24-hour Omeprazole Delayed-release tablets 20 mg Acid reducer Treats FREQUENT heartburn 24 HR May take 1 to 4 days for full effect Tablets Coated with Wildberry Flavor †This product is not affiliated with, manufactured by or produced by the makers or owners of Prilosec OTC®. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OR TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Manufactured by: Avema Pharma Solutions 10400 NW 29th Terrace Miami, FL 33172; Package label AVEMA PHARMA SOLUTION Acid Reducer Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium

Package Descriptions
  • Principal display panel †Compare to the active ingredient in Prilosec® OTC 24-hour Omeprazole Delayed-release tablets 20 mg Acid reducer Treats FREQUENT heartburn 24 HR May take 1 to 4 days for full effect Tablets Coated with Wildberry Flavor †This product is not affiliated with, manufactured by or produced by the makers or owners of Prilosec OTC®. TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OR TAMPERING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Manufactured by: Avema Pharma Solutions 10400 NW 29th Terrace Miami, FL 33172
  • Package label AVEMA PHARMA SOLUTION Acid Reducer Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium

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 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 everyday 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 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 (1-800-222-1222) right away.


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