omeprazole OMEPRAZOLE THE KROGER COMPANY 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
Generic: OMEPRAZOLE
Mfr: THE KROGER COMPANY FDA #7 OTC
FunFoxMeds bottle
Substance Omeprazole
Route
ORAL
Applications
ANDA207891

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each tablet) Omeprazole USP 20 mg
Inactive Ingredients
Inactive ingredients anhydrous lactose hypromellose hypromellose acetate succinate iron oxide red iron oxide yellow lactose monohydrate methyl cellulose monoethanolamine propylene glycol sodium lauryl sulfate sodium starch glycolate sodium stearate sodium stearyl fumarate talc triethyl citrate and titanium dioxide. The imprinting ink contains ammonium hydroxide black iron oxide n-butyl alcohol propylene glycol and shellac. Questions or Comments Call toll free 1-800-818-4555 weekdays.
Strengths
20 mg
Quantities
28 tablets
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: brown Imprint: 20

Identifiers & Packaging

Container Type BOTTLE
UPC
0041260009945
UNII
KG60484QX9
Packaging

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton COMPARE TO PRILOSEC OTC ® *See bottom panel NDC 30142-992-28 Kroger ® See new warning information Omeprazole Delayed-release Tablets 20 mg ACID REDUCER SWALLOW- DO NOT CHEW OUR PHARMACIST RECOMMENDED Treats FREQUENT Heartburn! 24 HR 28 TABLETS Two 14-Day Courses of Treatment May Take 1 to 4 Days for Full Effect actual size PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton COMPARE TO PRILOSEC OTC ® *See bottom panel NDC 30142-992-28 Kroger ® See new warning information Omeprazole Delayed-release Tablets 20 mg ACID REDUCER SWALLOW- DO NOT CHEW OUR PHARMACIST RECOMMENDED Treats FREQUENT Heartburn! 24 HR 28 TABLETS Two 14-Day Courses of Treatment May Take 1 to 4 Days for Full Effect actual size PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Carton

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 help right away. These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have: • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. 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 If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Purpose

Purpose Acid reducer

Keep Out of Reach of Children

Keep Out of Reach of Children

Questions

Questions or Comments Call toll free 1-800-818-4555 weekdays.


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