FDA.reportPublic FDA data

Calcarea Fluorica

Manufacturer
Warsan Homoeopathic
Effective date
2018-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:49:25

Label at a glance#

ProductCalcarea Fluorica
Active ingredientCALCIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNINGS SECTION

Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

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

OTC - ACTIVE INGREDIENT SECTION

Calcarea Fluorica 3X (HPUS)

OTC - PURPOSE SECTION

Temporary relief from minor joint pain, cracked skin, sensitive teeth

INACTIVE INGREDIENT SECTION

Latose.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: four tablets every thirty minutes for six doses followed by four tablets every 4-6 hours as needed.

Children 2 years to under 12 years: four tablets every thirty minutes for six doses followed by two tablets every 4-6 hours as needed.

Children under 2 years: Consult doctor prior to use.

INDICATIONS & USAGE SECTION

Temporary relief from minor joint pain, cracked skin, sensitive teeth.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

calc fluor 3x 1000.jpgcalc fluor 3x 1000.jpg

WARNINGS AND PRECAUTIONS SECTION

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69008-1000-12020-08-17C16284748780-19d75b9cf-e021-f424-e053-dadaa90a57ce6edb556c-f305-2f97-e053-2a91aa0a2391
69008-1000-12020-01-31C16284748780-19d75b9cf-e021-f424-e053-dadaa90a57ce6edb556c-f305-2f97-e053-2a91aa0a2391

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69008-100069008-1000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CALCIUM FLUORIDEO3B55K4YKIACTIB

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
ad154ec1-3b32-664f-e053-2995a90a0ada6edb556c-f305-2f97-e053-2a91aa0a23912020-08-17WarningsExact identifier
spl set id: 6edb556c-f305-2f97-e053-2a91aa0a2391

Reported adverse events (FAERS/openFDA)#

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