Drugplain

Prilosec OTC 20 mg/1

OMEPRAZOLE MAGNESIUM · TABLET, DELAYED RELEASE · The Procter & Gamble Manufacturing Company

1 Recall on RecordCurrently in Shortage
Plain English

Prilosec OTC is a tablet, delayed release containing omeprazole magnesium at 20 mg/1, taken oral. Manufactured by The Procter & Gamble Manufacturing Company.

Key Facts

Brand Name
Prilosec OTC
Generic Name
OMEPRAZOLE MAGNESIUM
NDC Code (Product)
37000-459
Manufacturer
The Procter & Gamble Manufacturing Company
Strength
20 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
NDA021229
Marketing Start
08/15/2012

Recall History

1 Recall on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

chronic kidney disease18,101 reports
acute kidney injury9,428 reports
renal failure7,621 reports
end stage renal disease5,800 reports
renal injury5,351 reports
tubulointerstitial nephritis2,341 reports
hyperchlorhydria2,165 reports
pain2,108 reports
rebound effect2,006 reports
gastrooesophageal reflux disease1,948 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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, crush, or suck 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

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.

Frequently Asked Questions

What is Prilosec OTC used for?

Prilosec OTC contains OMEPRAZOLE MAGNESIUM. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is Prilosec OTC a controlled substance?

Prilosec OTC is not classified as a controlled substance by the DEA.

What is the generic name for Prilosec OTC?

The generic name for Prilosec OTC is OMEPRAZOLE MAGNESIUM. There are 10 other brand versions of OMEPRAZOLE MAGNESIUM.

What is the NDC code for Prilosec OTC 20 mg/1?

The NDC (National Drug Code) for Prilosec OTC 20 mg/1 is 37000-459, listed by The Procter & Gamble Manufacturing Company.

Product NDC

37000-459

Package NDC

37000-459-01

Other Prilosec OTC Dosages

Other Omeprazole Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)