FDA.reportPublic FDA data

Calcium Carbonate

Manufacturer
Atlantic Biologicals Corps
Effective date
2025-05-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:00:51

Label at a glance#

ProductCalcium Carbonate
Active ingredientCALCIUM CARBONATE
Label structure10 sections

Indications and uses

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

Dosage and administration

Shake well before using. Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Storage and handling

store at 20° to 25°C (68° to 77°F) do not freeze packaged with tamper evident seal

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active ingredient (in each 5 mL teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 1250 mg (Equivalent to 500 mg elemental Calcium)

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves:

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

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Antacids may interact with certain prescription drugs.

OTC - WHEN USING SECTION

When using this product,do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • Take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store at 20° to 25°C (68° to 77°F)
  • do not freeze
  • packaged with tamper evident seal

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium saccharin, citric acid, D&C Red No. 33, FD&C Red No. 40, flavoring, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sorbitol and xanthan gum.

Questions?

OTC - QUESTIONS SECTION

Call 1-800-845-8210.

CALCIUM CARBONATE SUSPENSION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308891calcium carbonate 1250 MG in 5 mL Oral SuspensionPSN7
308891calcium carbonate 250 MG/ML Oral SuspensionSCD7
308891calcium carbonate 1250 MG (calcium 500 MG) per 5 ML Oral SuspensionSY7

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-3117-32025-03-18C16284748780-1f386c64a-2f2b-0266-e053-dadaa90a7c1aCalcium Carbonate
17856-3117-32023-01-30C16284748780-1f386c64a-2f2b-0266-e053-dadaa90a7c1aCalcium Carbonate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3117-3Calcium Carbonate5 mL in 1 CUPSUSPENSION57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3117CALCIUM CARBONATE SUSPENSION [ATLANTIC BIOLOGICALS CORPS]7Current NDC, Legacy NDC, 1 package rows20250514_38654d22-2f8a-49d2-a1cd-06d341f11323.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0766-16ML - Milliliter0121-0766a19d6d49-7c07-4740-a670-1066e0d061f512014-11-05

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17856-311717856-3117-3
0121-0766

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
D&C RED NO. 339DBA0SBB0LIACT
SACCHARIN CALCIUM5101OP7P2IIACT
WATER059QF0KO0RIACT
CALCIUM CARBONATEH0G9379FGKACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Calcium CarbonateCALCIUM CARBONATEAtlantic Biologicals Corps38654d22-2f8a-49d2-a1cd-06d341f113232025-05-12WarningsExact identifier
ndc (package): 17856-3117-3
ndc (product): 17856-3117
ndc11 (package): 17856311703
spl id: 34f3682a-e5bc-851a-e063-6394a90a8e96
spl set id: 38654d22-2f8a-49d2-a1cd-06d341f11323
Calcium CarbonateCALCIUM CARBONATEPAI Holdings, LLC dba PAI Pharmad89f3184-7081-4e16-a504-9214283891f62024-11-12WarningsExact identifier
ndc (product): 0121-0766

Reported adverse events (FAERS/openFDA)#

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