Drugplain

Antacid 400 mg/10mL

aluminum hydroxide, magnesium hydroxide, simethicone · LIQUID · Retail Business Services, LLC.

10 Recalls on Record
Plain English

Antacid is a liquid containing aluminum hydroxide, magnesium hydroxide, simethicone at 400 mg/10mL, taken oral. Manufactured by Retail Business Services, LLC..

Key Facts

Brand Name
Antacid
Generic Name
aluminum hydroxide, magnesium hydroxide, simethicone
NDC Code (Product)
72476-509
Manufacturer
Retail Business Services, LLC.
Strength
400 mg/10mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M001
Marketing Start
10/21/2021

Recall History

10 Recalls on Record
Class II05/28/2026

Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

OngoingVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II05/28/2026

Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

OngoingVoluntary: Firm initiated
Class II12/02/2022

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

CompletedVoluntary: Firm initiated
Class II05/28/2026

Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

OngoingVoluntary: Firm initiated
Class II03/30/2017

Bayer HealthCare Pharmaceuticals, Inc.

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

TerminatedVoluntary: Firm initiated
Class III12/18/2012

Belmora LLC

Defective Container: Product lacks tamper evident breakaway band on cap.

TerminatedVoluntary: Firm initiated
Class II12/02/2022

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

CompletedVoluntary: Firm initiated
Class II05/07/2018

RIJ Pharmaceutical LLC

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

TerminatedVoluntary: Firm initiated
Class II05/28/2026

Guardian Drug Co. Inc.

Presence of foreign substance: small metallic particles in chewable tablets.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

fatigue5,735 reports
off label use5,544 reports
nausea5,313 reports
drug ineffective5,159 reports
diarrhoea5,136 reports
pain4,883 reports
dyspnoea4,814 reports
vomiting4,487 reports
pneumonia4,076 reports
headache3,905 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses relieves: • heartburn • sour stomach • acid indigestion • upset stomach associated with these symptoms

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. Do not swallow tablets whole. • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor

Warnings

Warnings Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product • do not take more than 15 tablets in 24 hours • do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor

Frequently Asked Questions

What is Antacid used for?

Antacid contains aluminum hydroxide, magnesium hydroxide, simethicone. It is a liquid taken oral. Consult your doctor for specific uses.

Is Antacid a controlled substance?

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

What is the generic name for Antacid?

The generic name for Antacid is aluminum hydroxide, magnesium hydroxide, simethicone. There are 12 other brand versions of aluminum hydroxide, magnesium hydroxide, simethicone.

What is the NDC code for Antacid 400 mg/10mL?

The NDC (National Drug Code) for Antacid 400 mg/10mL is 72476-509, listed by Retail Business Services, LLC..