FDA.reportPublic FDA data

Silicea

Manufacturer
Warsan Homoeopathic Laboratories
Effective date
2018-06-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:54:29

Label at a glance#

ProductSilicea
Active ingredientSILICON DIOXIDE
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 health professional before use.

OTC - ACTIVE INGREDIENT SECTION

Silicea 12X (HPUS)

OTC - PURPOSE SECTION

Temorary relief from wounds, swelling, brittle nair, brittle nails.

INACTIVE INGREDIENT SECTION

Lactose.

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 age: Consult doctor prior to use.

INDICATIONS & USAGE SECTION

Temporary relief from wounds, swelling, brittle nair, brittle nails.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

silicea 12x 1035.jpgsilicea 12x 1035.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69008-1035-12020-08-17C16284748780-19d75b9d0-7eb5-f424-e053-dadaa90a57ce6ee032e8-e8cb-4ea9-e053-2991aa0aa2d9
69008-1035-12020-01-31C16284748780-19d75b9d0-7eb5-f424-e053-dadaa90a57ce6ee032e8-e8cb-4ea9-e053-2991aa0aa2d9

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69008-103569008-1035-1

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
LACTOSEJ2B2A4N98GIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB

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
ad168065-1e3b-752b-e053-2a95a90af9396ee032e8-e8cb-4ea9-e053-2991aa0aa2d92020-08-17WarningsExact identifier
spl set id: 6ee032e8-e8cb-4ea9-e053-2991aa0aa2d9

Reported adverse events (FAERS/openFDA)#

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