Omeprazole Magnesium 20.6mg Capsules

FDA Drug Profile — Omeprazole Magnesium

Drug Details

Generic Name
Omeprazole Magnesium 20.6mg Capsules
Brand Names
Omeprazole Magnesium
Application Number
ANDA078878
Sponsor
The Kroger Co.
NDC Codes
2
Dosage Forms
CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients
OMEPRAZOLE MAGNESIUM

Indications and 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

Warnings

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)