FDA.reportPublic FDA data

Calcium Carbonate

Manufacturer
Humco Holding Group, Inc. | Pharma Nobis, LLC
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:04:37

Label at a glance#

ProductCalcium Carbonate
Active ingredientCALCIUM CARBONATE
Label structure11 sections

Dosage and administration

Adults and children 6 yrs. of age and older: Take 1/2 level tsp. in 1/2 glass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate

Purpose

OTC - PURPOSE SECTION

Antacid

Use

INDICATIONS & USAGE SECTION

For relief of heartburn, acid ingestion, and upset stomach associated with these symptoms.

Warnings

WARNINGS SECTION

Except under the supervision of a doctor:

  • do not administer to children under 6 years of age.
  • do not take more than 3 teaspoonfuls in a 24 hour period.

OTC - WHEN USING SECTION

  • do not use the maximum dosge of this product for more than 2 weeks except under the advice and supervision of a doctor or other health professional.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you are preganant or nursing a baby.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, seek professional assistance or contact a Poison Control immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 yrs. of age and older: Take 1/2 level tsp. in 1/2 glass (4 fl oz) of water every 2 hrs. up to maximum dosage or as directed by a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CalCarb.jpgCalCarb.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-0431-01Calcium Carbonate454 g in 1 BOTTLE, PLASTICPOWDER4546

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-0431CALCIUM CARBONATE POWDER [HUMCO HOLDING GROUP, INC.]6Current NDC, Legacy NDC, 1 package rows20231216_8b207b49-d3fd-4108-b611-dca27c9dc78a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0395-0431-01GM - Gram0395-0431c5db51e5-697a-4558-8d6c-3a0479ee570512013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-04310395-0431-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CALCIUM CARBONATEH0G9379FGKACTIM

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 CARBONATEHumco Holding Group, Inc.8b207b49-d3fd-4108-b611-dca27c9dc78a2023-12-15WarningsExact identifier
ndc (package): 0395-0431-01
ndc (product): 0395-0431
ndc11 (package): 00395043101
spl id: 0c92bb26-9051-5952-e063-6294a90a481c
spl set id: 8b207b49-d3fd-4108-b611-dca27c9dc78a

Reported adverse events (FAERS/openFDA)#

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