Drugplain

Acid Reducer 75 mg/1

Ranitidine Hydrochloride · TABLET, FILM COATED · WinCo Foods, LLC

10 Recalls on Record
Plain English

Acid Reducer is a tablet, film coated containing ranitidine hydrochloride at 75 mg/1, taken oral. Manufactured by WinCo Foods, LLC.

Key Facts

Brand Name
Acid Reducer
Generic Name
Ranitidine Hydrochloride
NDC Code (Product)
67091-244
Manufacturer
WinCo Foods, LLC
Strength
75 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA201745
Marketing Start
08/02/2012

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

nausea33,623 reports
diarrhoea33,408 reports
fatigue32,404 reports
dyspnoea28,430 reports
drug ineffective26,713 reports
headache25,306 reports
off label use24,889 reports
vomiting23,434 reports
pain22,753 reports
dizziness21,291 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?

Acid Reducer contains Ranitidine Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

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 Ranitidine Hydrochloride. There are 2 other brand versions of Ranitidine Hydrochloride.

What is the NDC code for Acid Reducer 75 mg/1?

The NDC (National Drug Code) for Acid Reducer 75 mg/1 is 67091-244, listed by WinCo Foods, LLC.

Product NDC

67091-244

Package NDC

67091-244-30

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

Data from openFDA · Public domain (CC0 1.0)