FDA.reportPublic FDA data

Calcium Carbonate

Manufacturer
Allegiant Health
Effective date
2025-02-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:28

Label at a glance#

ProductCalcium Carbonate
Active ingredientCALCIUM CARBONATE
Label structure9 sections

Dosage and administration

chew 2 tablets every 2-3 hours or as symptoms occur, repeat hourly if needed

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 420mg

Purpose

OTC - PURPOSE SECTION

Antacid

Use(s)

INDICATIONS & USAGE SECTION

relieves

  • heartburn
  • sour stomach
  • acid indigestion
  • upset stomach due to these symptoms

Warnings

WARNINGS SECTION

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

  • have kidney disease
  • are taking a prescription drug
    Antacids may interact with certain prescription drugs

When using this product

OTC - WHEN USING SECTION

do not take more than 19 tablets in a 24 hour period or use the maximum dosage
of this product for more than two weeks except under the advice and supervision of a doctor. If symptoms
persist for more than two weeks, stop using this product and see a doctor.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • chew 2 tablets every 2-3 hours or as symptoms occur, repeat hourly if needed

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 168mg
  • Phenylketonurics: Contains phenylalanine 1.5 mg per tablet 
  • 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

aspartame, croscarmellose sodium, magnesium stearate, maltodextrin, mint flavor, sorbitol

Questions/Comments

OTC - QUESTIONS SECTION

Call 1-888-952-0050 

Monday through Friday 9AM to 5PM EST.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calcium Carbonate 420mg
Calcium Carbonate 420mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN1
313884calcium carbonate 420 MG Chewable TabletSCD1
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-036-54Calcium Carbonate22058 in 1 BAGTABLET, CHEWABLE220581

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-036CALCIUM CARBONATE TABLET, CHEWABLE [ALLEGIANT HEALTH]1Current NDC, 1 package rows20250303_9bc5c5de-8d61-4edf-83d2-a1e797c2d24a.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
69168-03669168-036-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIB
ASPARTAMEZ0H242BBR1IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
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 CarbonateCALCIUM CARBONATEAllegiant Health9bc5c5de-8d61-4edf-83d2-a1e797c2d24a2025-02-28WarningsExact identifier
ndc (package): 69168-036-54
ndc (product): 69168-036
ndc11 (package): 69168003654
spl id: 81b779be-6a56-469e-8715-ded51bcb2c3a
spl set id: 9bc5c5de-8d61-4edf-83d2-a1e797c2d24a

Reported adverse events (FAERS/openFDA)#

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