FDA.reportPublic FDA data

639R CVS Calcium Carbonate 1000 mg Chewable Tablets - Tropical Fruit

Manufacturer
CVS HEALTH CORP | TIME CAP LABORATORIES, INC. | MARKSANS PHARMA LIMITED
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:59:04

Label at a glance#

ProductCalcium Carbonate 1000 mg
Active ingredientCALCIUM CARBONATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (per tablet)

Calcium Carbonate USP 1000 mg

OTC - PURPOSE SECTION

Purpose

Antacid

INDICATIONS & USAGE SECTION

Uses relieves

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

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

  • do not take more than 7 tablets in 24 hours
  • if pregnant do not take more than 5 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks, except under the advice and supervision of a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 12 years of age and over: chew 2-3 tablets as symptoms occur, or as directed by a doctor. Chew or crush tablets completely before swallowing.
  • do not take for symptoms that persist for more than 2 weeks unless advised by a doctor.

OTHER SAFETY INFORMATION

Other information

  • each tablet contains: elemental calcium 400 mg, magnesium 12 mg
  • store at room temperature. Keep the container tightly closed.

INACTIVE INGREDIENT SECTION

Inactive ingredients adipic acid, corn starch, dextrose anhydrous, FD&C red 40 Al lake, FD&C yellow #5 Al lake, FD&C yellow #6 Al lake, flavors, magnesium stearate, maltodextrin, sucralose

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

639R_72ct_Lbl639R_72ct_Lbl

639R_160ct_Lbl639R_160ct_Lbl

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308892calcium carbonate 1000 MG (Ca 400 MG) Chewable TabletPSN2
308892calcium carbonate 1000 MG Chewable TabletSCD2
308892calcium carbonate 1000 MG (calcium 400 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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
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
51316-639-66Calcium Carbonate 1000 mg160 in 1 BOTTLETABLET, CHEWABLE1602
51316-639-75Calcium Carbonate 1000 mg72 in 1 BOTTLETABLET, CHEWABLE722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-639CALCIUM CARBONATE 1000 MG (CALCIUM CARBONATE 1000 MG - TROPICAL FRUIT) TABLET, CHEWABLE [CVS HEALTH CORP]2Current NDC, 2 package rows20250416_24ceba32-eb32-902f-e063-6394a90a9fd5.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-63951316-639-75, 51316-639-66

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
CALCIUM CARBONATEH0G9379FGKACTIB
ADIPIC ACID76A0JE0FKJIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
MALTODEXTRIN7CVR7L4A2DIACT
SUCRALOSE96K6UQ3ZD4IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
MAGNESIUM STEARATE70097M6I30IACT

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 Carbonate 1000 mgCALCIUM CARBONATE 1000 MG - TROPICAL FRUITCVS HEALTH CORP24ceba32-eb32-902f-e063-6394a90a9fd52025-03-28WarningsExact identifier
ndc (package): 51316-639-66
ndc (package): 51316-639-75
ndc (product): 51316-639
ndc11 (package): 51316063975
ndc11 (package): 51316063966
spl id: 31616619-f82f-d51b-e063-6294a90a6047
spl set id: 24ceba32-eb32-902f-e063-6394a90a9fd5

Reported adverse events (FAERS/openFDA)#

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