Drugplain

ANTACID 648 mg/1

Calcium Carbonate · TABLET · Advance Pharmaceutical Inc.

10 Recalls on RecordCurrently in Shortage
Plain English

ANTACID is a tablet containing calcium carbonate at 648 mg/1, taken oral. Manufactured by Advance Pharmaceutical Inc..

Key Facts

Brand Name
ANTACID
Generic Name
Calcium Carbonate
NDC Code (Product)
17714-025
Manufacturer
Advance Pharmaceutical Inc.
Strength
648 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
part331
Marketing Start
04/06/1990

Recall History

10 Recalls on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

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 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 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 II01/26/2022

ULTRAtab Laboratories, Inc.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II05/28/2020

Glaxosmithkline Consumer Healthcare Holdings

Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.

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

Side Effects Reported to FDA

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

fatigue5,735 reports
off label use5,545 reports
nausea5,315 reports
drug ineffective5,160 reports
diarrhoea5,137 reports
pain4,885 reports
dyspnoea4,818 reports
vomiting4,488 reports
pneumonia4,078 reports
headache3,907 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 Calcium Carbonate. It is a tablet 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 Calcium Carbonate. There are 12 other brand versions of Calcium Carbonate.

What is the NDC code for ANTACID 648 mg/1?

The NDC (National Drug Code) for ANTACID 648 mg/1 is 17714-025, listed by Advance Pharmaceutical Inc..