Drugplain

Calcium Carbonate 1250 mg/5mL

Calcium Carbonate · SUSPENSION · PAI Holdings, LLC dba PAI Pharma

10 Recalls on RecordCurrently in Shortage
Plain English

Calcium Carbonate is a suspension containing calcium carbonate at 1250 mg/5mL, taken oral. Manufactured by PAI Holdings, LLC dba PAI Pharma.

Key Facts

Brand Name
Calcium Carbonate
Generic Name
Calcium Carbonate
NDC Code (Product)
0121-4766
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Strength
1250 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
M001
Marketing Start
12/01/2004

Recall History

10 Recalls on Record
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 II07/07/2016

Safecor Health, LLC

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II07/02/2013

Aidapak Services, LLC

Labeling: Label Mixup; CALCIUM CARBONATE +D3, Tablet, 600 mg/400 units may be potentially mis-labeled as DIGOXIN, Tablet, 125 mcg, NDC 00527132401, Pedigree: AD76675_4, EXP: 6/3/2014; or AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_4, EXP: 5/20/2014.

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 II01/26/2022

ULTRAtab Laboratories, Inc.

CGMP Deviations

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 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 II01/26/2022

ULTRAtab Laboratories, Inc.

CGMP Deviations

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 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
nausea4,206 reports
off label use4,118 reports
pain4,013 reports
dyspnoea3,807 reports
drug ineffective3,715 reports
diarrhoea3,694 reports
vomiting3,568 reports
pneumonia3,169 reports
headache3,160 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 and swallow 2-4 tablets as symptoms occur, or as directed by a doctor. Do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

Warnings

Warnings Warnings Ask a doctor or pharmacist before use if you are presently taking a prescription drug. Antacids may interact with certain prescription drugs. When using this product do not take more than 10 tablets in 24 hours if pregnant, do not take more than 6 tablets in 24 hours do not use the maximum dosage for more than 2 weeks except under the advice and supervision of a doctor Keep out of reach of children.

Frequently Asked Questions

What is Calcium Carbonate used for?

Calcium Carbonate contains Calcium Carbonate. It is a suspension taken oral. Consult your doctor for specific uses.

Is Calcium Carbonate a controlled substance?

Calcium Carbonate is not classified as a controlled substance by the DEA.

What is the generic name for Calcium Carbonate?

The generic name for Calcium Carbonate is Calcium Carbonate. There are 12 other brand versions of Calcium Carbonate.

What is the NDC code for Calcium Carbonate 1250 mg/5mL?

The NDC (National Drug Code) for Calcium Carbonate 1250 mg/5mL is 0121-4766, listed by PAI Holdings, LLC dba PAI Pharma.