Acid Reducer OMEPRAZOLE NORTHEAST PHARMA 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
Generic: OMEPRAZOLE
Mfr: NORTHEAST PHARMA FDA #7 OTC
FunFoxMeds bottle
Route
ORAL
Applications
ANDA206877

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)
Inactive Ingredients
Inactive ingredients crospovidone glyceryl monostearate hydroxypropyl cellulose hypromellose magnesium stearate methacrylic acid and ethyl acrylate copolymer dispersion microcrystalline cellulose polyethylene glycol polysorbate 80 red iron oxide silicified microcrystalline cellulose sodium hydroxide sodium stearyl fumarate sugar spheres [which contains liquid glucose starch (maize) and sucrose] talc titanium dioxide triethyl citrate and yellow iron oxide.
Strengths
20 mg 20.6 mg
Quantities
14 tablet 14 tablets 42 tablets
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: rectangle Color: pink Imprint: Z;69

Identifiers & Packaging

Container Type BOTTLE
UNII
426QFE7XLK
Packaging

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle) Heartland TM Pharma Co. NDC 80136-852-01 OMEPRAZOLE Delayed-Release Tablets 20 mg Acid Reducer 24 Hour Treats Frequent Heartburn! One 14-day course of treatment May Take 1 to 4 Days for full effect 14 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets Bottle Carton Label) Heartland TM Pharma Co. NDC 80136-852-03 OMEPRAZOLE Delayed-Release Tablets 20 mg Acid Reducer 24 Hour Treats Frequent Heartburn! Compare to active ingredient in PRILOSEC OTC ®* Actual Size Three 14-day courses of treatment May Take 1 to 4 Days for full effect 42 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets Blister Carton Label); PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets Blister Carton Label) NDC 80136-852-42 Heartland TM Pharma Co. OMEPRAZOLE Delayed-Release Tablets 20 mg Acid Reducer Treats Frequent Heartburn! 24 Hour Compare to active ingredient in PRILOSEC OTC ®* Actual Size Three 14-day courses of treatment May Take 1 to 4 Days for full effect 42(3x14) Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets Blister Carton Label)

Package Descriptions
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle) Heartland TM Pharma Co. NDC 80136-852-01 OMEPRAZOLE Delayed-Release Tablets 20 mg Acid Reducer 24 Hour Treats Frequent Heartburn! One 14-day course of treatment May Take 1 to 4 Days for full effect 14 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets Bottle Carton Label) Heartland TM Pharma Co. NDC 80136-852-03 OMEPRAZOLE Delayed-Release Tablets 20 mg Acid Reducer 24 Hour Treats Frequent Heartburn! Compare to active ingredient in PRILOSEC OTC ®* Actual Size Three 14-day courses of treatment May Take 1 to 4 Days for full effect 42 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets Blister Carton Label)
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets Blister Carton Label) NDC 80136-852-42 Heartland TM Pharma Co. OMEPRAZOLE Delayed-Release Tablets 20 mg Acid Reducer Treats Frequent Heartburn! 24 Hour Compare to active ingredient in PRILOSEC OTC ®* Actual Size Three 14-day courses of treatment May Take 1 to 4 Days for full effect 42(3x14) Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets Blister Carton Label)

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 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
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.

Storage & Handling

Other information read the directions and warnings before use keep the carton. It contains important information. store at 20º to 25ºC (68º to 77º F) and protect from moisture

Questions

Questions? Call 1-800-383-0648 Distributed by: NORTHEAST PHARMA South Burlington, VT 05403 www.heartlandpharmaco.com Made in India Code: TS/DRUGS/22/2009


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