FDA.reportPublic FDA data

Calcium Carbonate 500 mg

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:52:51

Label at a glance#

ProductCalcium Carbonate 500 mg
Active ingredientCALCIUM CARBONATE
Label structure13 sections

Dosage and administration

Adults and children 12 years and over: chew 2-4 tablets as symptoms occur do not take more than 8 tablets in 24 hours do not use the maximum dosage for more than 2 weeks children under 12 years: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 500 mg

Purpose

OTC - PURPOSE SECTION

Antacid

INDICATIONS & USAGE SECTION

Uses relieves

  • acid indigestion
  • heartburn
  • sour stomach

Warnings

WARNINGS SECTION

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

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

Keep out of reach of children.

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and over:

  • chew 2-4 tablets as symptoms occur
  • do not take more than 8 tablets in 24 hours
  • do not use the maximum dosage for more than 2 weeks

children under 12 years:

ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 200 mg
  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Al-lakes (D&C red #27, D&C yellow #10, FD&C blue #1, FD&C yellow #6), dextrose, flavors, magnesium stearate, maltodextrin

Questions or comments?

OTC - QUESTIONS SECTION

call 516-341-0666, 8:30 am - 4:30 pm ET, Monday-Friday

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-020-15 *Compare to Active Ingredient of Tums® Regular Strength

ASSORTED FLAVORS

Calcium Carbonate

500 mg

ANTACID

150 CHEWABLE TABLETS

*Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Tums®

Calcium Carbonate 500 mgCalcium Carbonate 500 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308907calcium carbonate 500 MG (Ca 200 MG) Chewable TabletPSN7
308907calcium carbonate 500 MG Chewable TabletSCD7
308907calcium carbonate 500 MG (equivalent to calcium 200 MG) Chewable TabletSY7

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-020-152023-03-29C16284748780-1f386c649-d9dc-0266-e053-dadaa90a7c1aCalcium Carbonate 500 mg
69618-020-152023-01-30C16284748780-1f386c649-d9dc-0266-e053-dadaa90a7c1aCalcium Carbonate 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-020-15Calcium Carbonate 500 mg150 in 1 BOTTLE, PLASTICTABLET, CHEWABLE1507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-020CALCIUM CARBONATE 500 MG (CALCIUM CARBONATE) TABLET, CHEWABLE [RELIABLE 1 LABORATORIES LLC]7Current NDC, Legacy NDC, 1 package rows20250117_322f1b54-abe9-11a7-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-020-15EA - Each69618-02036dad116-9c2e-4050-aa80-4cfba851f1c812016-05-16

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-02069618-020-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 6H77VEI93A8IACT
MAGNESIUM STEARATE70097M6I30IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 272LRS185U6KIACT
DEXTROSEIY9XDZ35W2IACT
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 Carbonate 500 mgCALCIUM CARBONATEReliable 1 Laboratories LLC322f1b54-abe9-11a7-e054-00144ff8d46c2025-01-15WarningsExact identifier
ndc (package): 69618-020-15
ndc (product): 69618-020
ndc11 (package): 69618002015
spl id: 2bc80ff5-2de4-ff04-e063-6294a90a5026
spl set id: 322f1b54-abe9-11a7-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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