Omeprazole Magnesium OMEPRAZOLE MAGNESIUM CAPSULES THE KROGER CO. 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
FunFoxMeds bottle
Route
ORAL
Applications
ANDA078878

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient(in each capsule) Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Inactive Ingredients
Inactive ingredients black iron oxide dibasic calcium phosphate gelatin glyceryl monostearate hypromellose 3 cps magnesium oxide magnesium stearate methacrylic acid copolymer dispersion methacrylic acid copolymer Type B microcrystalline cellulose polysorbate 80 potassium hydroxide propylene glycol red iron oxide shellac silicon dioxide sodium lauryl sulphate sugar spheres 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

Identifiers & Packaging

Container Type BOTTLE
UNII
426QFE7XLK
Packaging

Carton label Kroger NDC 30142-012-33 Omeprazole Delayed-Release Capsules 20 mg* ACID REDUCER Treats Frequent Heartburn May take 1 to 4 days for full effect Three 14-Day Courses of Treatment 42 SAFETY SEALED CAPSULES; Bottle label Kroger Omeprazole Delayed-Release Capsules 20 mg* ACID REDUCER Treats Frequent Heartburn ONE 14-Day Course of Treatment May take 1 to 4 days for full effect 14 SAFETY SEALED CAPSULES

Package Descriptions
  • Carton label Kroger NDC 30142-012-33 Omeprazole Delayed-Release Capsules 20 mg* ACID REDUCER Treats Frequent Heartburn May take 1 to 4 days for full effect Three 14-Day Courses of Treatment 42 SAFETY SEALED CAPSULES
  • Bottle label Kroger Omeprazole Delayed-Release Capsules 20 mg* ACID REDUCER Treats Frequent Heartburn ONE 14-Day Course of Treatment May take 1 to 4 days for full effect 14 SAFETY SEALED CAPSULES

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 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 do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew or crush capsules. 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 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. 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: warfarin, clopidogrel or cilostazol (blood-thinning medicines) prescription antifungal or anti-yeast medicines diazepam (anxiety medicine) digoxin (heart medicine) tacrolimus or mycophenolate mofetil (immune system medicines) prescription antiretrovirals (medicines for HIV infection) methotrexate (arthritis medicine) Stop use and ask 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 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

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 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

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. (1-800-222-1222)

Storage & Handling

Storage store at 20 – 25°C (68 – 77° F) and protect from moisture

Questions

Questions? call 1-800-632-6900


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