FDA.reportPublic FDA data

Calsium Carbonate 10 gr

Manufacturer
Reliable 1 Laboratories LLC
Effective date
2021-10-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:44:33

Label at a glance#

ProductCalsium Carbonate 10 gr
Active ingredientCALCIUM CARBONATE
Label structure15 sections

Indications and uses

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

Dosage and administration

take one to four tablets daily do not take more than 4 tablets in 23 hours do not use the maximun dosage for more than 2 weeks

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Calcium carbonate 10 gr

Purpose

OTC - PURPOSE SECTION

Antacid

Uses

INDICATIONS & USAGE SECTION

relieves

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

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.

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

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 a doctor if symptoms last more than 2 weeks.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take one to four tablets daily
  • do not take more than 4 tablets in 23 hours
  • do not use the maximun dosage for more than 2 weeks

Other information

SPL UNCLASSIFIED SECTION

  • each tablet contains: calcium 260 mg
  • store at room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, magnesium stearate, maltodextrin, microcrystalline cellulose, stearic acid

Question or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

SPL UNCLASSIFIED SECTION

Distributed by: Reliable 1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69618-021-10

Calcium Carbonate 10 gr

ANTACID

1000 TABLETS

CALCIUM CARBONATECALCIUM CARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577040calcium carbonate 648 MG (Ca 260 MG) Oral TabletPSN3
577040calcium carbonate 648 MG Oral TabletSCD3
577040calcium carbonate 648 MG (as calcium 260 MG) Oral TabletSY3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-021-102023-01-30C16284748780-19d75b9d0-6cc7-f424-e053-dadaa90a57ceReliable-1 Calcium Carbonate 10 gr
69618-021-102021-08-09C16284748780-19d75b9d0-6cc7-f424-e053-dadaa90a57ceReliable-1 Calcium Carbonate 10 gr
69618-021-102020-01-31C16284748780-19d75b9d0-6cc7-f424-e053-dadaa90a57ceReliable-1 Calcium Carbonate 10 gr

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-021-10Calsium Carbonate 10 gr1000 in 1 BOTTLE, PLASTICTABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-021CALSIUM CARBONATE 10 GR (CALCIUM CARBONATE) TABLET [RELIABLE 1 LABORATORIES LLC]3Legacy NDC, 1 package rows20211029_32bc07dc-7a94-63ed-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-021-10EA - Each69618-021ad819511-448b-496f-9b48-18ea4a2cf29012016-05-16

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69618-02169618-021-10

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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
STEARIC ACID4ELV7Z65APIACT
MALTODEXTRIN7CVR7L4A2DIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
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
cf5ebcfc-abec-602e-e053-2a95a90a46e832bc07dc-7a94-63ed-e054-00144ff8d46c2021-10-27WarningsExact identifier
spl id: cf5ebcfc-abec-602e-e053-2a95a90a46e8
spl set id: 32bc07dc-7a94-63ed-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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