Drugplain

Acid Reducer 20 mg/1

Omeprazole · TABLET, DELAYED RELEASE · Bi-Mart

10 Recalls on RecordCurrently in Shortage
Plain English

Omeprazole is a medication that reduces stomach acid and is used to treat heartburn, acid reflux, and related conditions. This over-the-counter tablet form allows you to take it by mouth to help relieve these symptoms.

Key Facts

Brand Name
Acid Reducer
Generic Name
Omeprazole
NDC Code (Product)
37835-189
Manufacturer
Bi-Mart
Strength
20 mg/1
Dosage Form
TABLET, DELAYED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA206877
Marketing Start
06/06/2018

Recall History

10 Recalls on Record
Class II03/27/2024

NATCO Pharma Limited

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II09/24/2019

Apotex Inc.

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

CompletedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated
Class II10/23/2019

Perrigo Company PLC

CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

nausea33,626 reports
diarrhoea33,406 reports
fatigue32,407 reports
dyspnoea28,430 reports
drug ineffective26,714 reports
headache25,306 reports
off label use24,889 reports
vomiting23,438 reports
pain22,753 reports
dizziness21,293 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 adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 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 • swallow whole. Do not crush or chew capsules. • do not use for more than 14 days unless directed by your doctor 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 before use. Heartburn in children may sometimes be caused by a serious condition .

Warnings

Warnings Allergy alert : Do not use if you are allergic to esomeprazole. Esomeprazole 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 Acid Reducer used for?

Omeprazole is a medication that reduces stomach acid and is used to treat heartburn, acid reflux, and related conditions. This over-the-counter tablet form allows you to take it by mouth to help relieve these symptoms.

Is Acid Reducer a controlled substance?

Acid Reducer is not classified as a controlled substance by the DEA.

What is the generic name for Acid Reducer?

The generic name for Acid Reducer is Omeprazole. There are 11 other brand versions of Omeprazole.

What is the NDC code for Acid Reducer 20 mg/1?

The NDC (National Drug Code) for Acid Reducer 20 mg/1 is 37835-189, listed by Bi-Mart.