Drugplain

Prilosec 10 mg/1

omeprazole magnesium · GRANULE, DELAYED RELEASE · Covis Pharma US, Inc

2 Recalls on RecordCurrently in Shortage
Plain English

Prilosec is a granule, delayed release containing omeprazole magnesium at 10 mg/1, taken oral. Manufactured by Covis Pharma US, Inc.

Key Facts

Brand Name
Prilosec
Generic Name
omeprazole magnesium
NDC Code (Product)
70515-610
Manufacturer
Covis Pharma US, Inc
Strength
10 mg/1
Dosage Form
GRANULE, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
NDA022056
Marketing Start
08/25/2017

Recall History

2 Recalls on Record
Class II03/15/2021

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

TerminatedVoluntary: Firm initiated
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 disease31,877 reports
acute kidney injury16,339 reports
renal failure13,410 reports
end stage renal disease9,346 reports
renal injury8,594 reports
drug ineffective6,968 reports
nausea6,627 reports
pain6,471 reports
fatigue5,783 reports
diarrhoea5,362 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 used for?

Prilosec contains omeprazole magnesium. It is a granule, delayed release taken oral. Consult your doctor for specific uses.

Is Prilosec a controlled substance?

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

What is the generic name for Prilosec?

The generic name for Prilosec is omeprazole magnesium. There are 10 other brand versions of omeprazole magnesium.

What is the NDC code for Prilosec 10 mg/1?

The NDC (National Drug Code) for Prilosec 10 mg/1 is 70515-610, listed by Covis Pharma US, Inc.

Product NDC

70515-610

Package NDC

70515-610-01

Other Prilosec Dosages

Other Omeprazole Brands

See all →

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

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