Drugplain

REGULAR STRENGTH ANTACID 200 mg/5mL

aluminum hydroxide, magnesium hydroxide, dimethicone · SUSPENSION · Chain Drug Marketing Association

5 Recalls on Record
Plain English

This oral suspension contains aluminum hydroxide, magnesium hydroxide, and dimethicone and is used to relieve heartburn, acid indigestion, and upset stomach. It works by neutralizing stomach acid and reducing gas bubbles that can cause bloating and discomfort.

Key Facts

Brand Name
REGULAR STRENGTH ANTACID
Generic Name
aluminum hydroxide, magnesium hydroxide, dimethicone
NDC Code (Product)
63868-712
Manufacturer
Chain Drug Marketing Association
Strength
200 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
M001
Marketing Start
03/01/2014

Recall History

5 Recalls on Record
Class II04/16/2015

Tarmac Products, Inc.

Products failed the Antimicrobial Effectiveness Test.

TerminatedVoluntary: Firm initiated
Class II02/06/2015

Tarmac Products, Inc.

Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.

TerminatedVoluntary: Firm initiated
Class III08/06/2013

Novartis Consumer Health

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

TerminatedVoluntary: Firm initiated
Class II03/16/2013

Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.

TerminatedVoluntary: Firm initiated
Class III08/06/2013

Novartis Consumer Health

Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue4,772 reports
nausea4,209 reports
off label use4,120 reports
pain4,014 reports
dyspnoea3,808 reports
drug ineffective3,715 reports
diarrhoea3,695 reports
vomiting3,568 reports
pneumonia3,170 reports
headache3,161 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

USE(S) relieves: acid indigestion heartburn

Dosage & Administration

DIRECTIONS adults and children 12 years of age and over: chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Warnings

WARNINGS .

Frequently Asked Questions

What is REGULAR STRENGTH ANTACID used for?

This oral suspension contains aluminum hydroxide, magnesium hydroxide, and dimethicone and is used to relieve heartburn, acid indigestion, and upset stomach. It works by neutralizing stomach acid and reducing gas bubbles that can cause bloating and discomfort.

Is REGULAR STRENGTH ANTACID a controlled substance?

REGULAR STRENGTH ANTACID is not classified as a controlled substance by the DEA.

What is the generic name for REGULAR STRENGTH ANTACID?

The generic name for REGULAR STRENGTH ANTACID is aluminum hydroxide, magnesium hydroxide, dimethicone. There are 11 other brand versions of aluminum hydroxide, magnesium hydroxide, dimethicone.

What is the NDC code for REGULAR STRENGTH ANTACID 200 mg/5mL?

The NDC (National Drug Code) for REGULAR STRENGTH ANTACID 200 mg/5mL is 63868-712, listed by Chain Drug Marketing Association.