Drugplain

Omeprazole Magnesium 20 mg/1

Omeprazole Magnesium · CAPSULE, DELAYED RELEASE · Albertsons Companies

2 Recalls on RecordCurrently in Shortage
Plain English

Omeprazole Magnesium is a capsule, delayed release containing omeprazole magnesium at 20 mg/1, taken oral. Manufactured by Albertsons Companies.

Key Facts

Brand Name
Omeprazole Magnesium
Generic Name
Omeprazole Magnesium
NDC Code (Product)
21130-398
Manufacturer
Albertsons Companies
Strength
20 mg/1
Dosage Form
CAPSULE, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA078878
Marketing Start
02/01/2016

Recall History

2 Recalls on Record
Class II10/05/2021

Dr. Reddy's Laboratories, Inc.

CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.

TerminatedVoluntary: Firm initiated
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease1,814 reports
acute kidney injury933 reports
end stage renal disease643 reports
renal failure517 reports
renal injury385 reports
gastrooesophageal reflux disease331 reports
tubulointerstitial nephritis201 reports
drug ineffective200 reports
pain199 reports
nausea185 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 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

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. 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 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 preg

Frequently Asked Questions

What is Omeprazole Magnesium used for?

Omeprazole Magnesium contains Omeprazole Magnesium. It is a capsule, delayed release taken oral. Consult your doctor for specific uses.

Is Omeprazole Magnesium a controlled substance?

Omeprazole Magnesium is not classified as a controlled substance by the DEA.

What is the generic name for Omeprazole Magnesium?

The generic name for Omeprazole Magnesium is Omeprazole Magnesium. There are 8 other brand versions of Omeprazole Magnesium.

What is the NDC code for Omeprazole Magnesium 20 mg/1?

The NDC (National Drug Code) for Omeprazole Magnesium 20 mg/1 is 21130-398, listed by Albertsons Companies.