FDA.reportPublic FDA data

Calcium Carbonate

Manufacturer
Allegiant Health
Effective date
2025-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:18

Label at a glance#

ProductCalcium Carbonate
Active ingredientCALCIUM CARBONATE
Label structure9 sections

Dosage and administration

chew 2-4 tablets as symptoms occur, repeat hourly if needed

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate USP 500mg

Purpose

OTC - PURPOSE SECTION

Antacid

Use(s)

INDICATIONS & USAGE SECTION

relieves 

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach associated with these symptoms

Warnings

WARNINGS SECTION

Ask a doctor before use if you

OTC - ASK DOCTOR SECTION

  • kidney disease
  • taking any prescription drugs; antacids may interact with certain prescription drugs

When using this product

OTC - WHEN USING SECTION

do not take more than 15 tablets in a 24 our period or use the maximum dosage of this product
for more than 2 weeks.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

chew 2-4 tablets as symptoms occur, repeat hourly if needed

Other information

SPL UNCLASSIFIED SECTION

  • Calcium content per tablets: 200mg
  • store at 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or
    missing  

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, orange flavor, sorbitol

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calcium Carbonate 500mg
Calcium Carbonate 500mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN2
308907calcium carbonate 500 MG Chewable TabletSCD2
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-124-54Calcium Carbonate15000 in 1 BAGTABLET, CHEWABLE150002
69168-124-54Calcium Carbonate1 in 1 BOXTABLET, CHEWABLE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-124CALCIUM CARBONATE (ANTACID) TABLET, CHEWABLE [ALLEGIANT HEALTH]2Current NDC, 2 package rows20250504_5397b702-5920-4af9-8cc5-e7fe6e2c1021.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-12469168-124-54

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium CarbonateANTACIDAllegiant Health5397b702-5920-4af9-8cc5-e7fe6e2c10212025-05-01WarningsExact identifier
ndc (package): 69168-124-54
ndc (product): 69168-124
ndc11 (package): 69168012454
spl id: 21617025-edb3-4f7b-bbf0-c5fab44c6393
spl set id: 5397b702-5920-4af9-8cc5-e7fe6e2c1021

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.