FDA.reportPublic FDA data

CALCIUM CARBONATE

Manufacturer
Blessings International | Geri-Care Pharmaceutical Corp
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:45

Label at a glance#

ProductCALCIUM CARBONATE
Active ingredientCALCIUM CARBONATE
Label structure8 sections

Indications and uses

temporarily relieves: acid indigestion heartburn sour stomach

Dosage and administration

• do not exceed recommended dose • adults and children 12 years of age and older: • chew 2 to 4 tablets as symptoms occur, or as directed by a doctor • do not take more than 15 tablets in 24 hours • if pregnant, do not take more than 10 tablets in 24 hours • children under 12 years: ask a doctor

Storage and handling

each tablet contains: calcium 200 mg Store below 30°C (86°F). Keep the container tightly closed. Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 500 mg

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

temporarily relieves:

  • acid indigestion
  • heartburn
  • sour stomach

Warnings

WARNINGS SECTION

Ask a doctor before use if you have kidney stones.

Ask a doctor before use if you are taking prescription drugs. Antacids may interact with certain prescription drugs.

Stop use and ask a doctor if symptoms last more than 2 weeks.

When using this product do not use the maximum dosage for more than 2 weeks

If pregnant or breast feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not exceed recommended dose
• adults and children 12 years of age and older:
• chew 2 to 4 tablets as symptoms occur, or as directed by a doctor
• do not take more than 15 tablets in 24 hours
• if pregnant, do not take more than 10 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 200 mg
  • Store below 30°C (86°F). Keep the container tightly closed.
  • Tamper Evident: Do not use if imprinted seal under cap is
    missing or broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

assorted flavors, D&C Yellow #10 lake, dextrose, FD&C Blue #1 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, magnesium stearate, maltodextrin

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN3
308907calcium carbonate 500 MG Chewable TabletSCD3
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY3

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51376-127-05CALCIUM CARBONATE500 in 1 BOTTLETABLET, CHEWABLE5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51376-127CALCIUM CARBONATE TABLET, CHEWABLE [BLESSINGS INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20231026_99d7e467-a3db-b4f0-e053-2a95a90a900f.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51376-12751376-127-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSEIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MAGNESIUM STEARATE70097M6I30IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CALCIUM CARBONATECALCIUM CARBONATEBlessings International99d7e467-a3db-b4f0-e053-2a95a90a900f2023-10-25WarningsExact identifier
ndc (package): 51376-127-05
ndc (product): 51376-127
ndc11 (package): 51376012705
spl id: 088e9dab-a2f3-f690-e063-6294a90a65ac
spl set id: 99d7e467-a3db-b4f0-e053-2a95a90a900f

Reported adverse events (FAERS/openFDA)#

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