#12 SILICEA 6X 500 Tablets

Manufacturer
Hyland's Inc.
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:18:58

Label at a glance#

ProductSILICEA
Active ingredientSILICON DIOXIDE
Label structure6 sections

Dosage and administration

Adults & Children ages 6 - 12: 4 tablets. Children ages 2 - 6: 2 tablets. Dissolve under tongue 3 times a day. Use more frequently (every 15 minutes for up to 8 doses) with acute conditions.

Label contents#

Full prescribing information#

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults & Children ages 6 - 12: 4 tablets. Children ages 2 - 6: 2 tablets. Dissolve under tongue 3 times a day. Use more frequently (every 15 minutes for up to 8 doses) with acute conditions.

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Relief of symptoms of skin ailments including pimples, blackheads and blemishes associated with common acne. Relief of symptoms of brittle hair and nails.

FORMULA

OTC - ACTIVE INGREDIENT SECTION

Silicea 6X HPUS

INACTIVE INGREDIENT SECTION

in a base of Acacia Gum, Lactose N.F.

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use if imprinted cap band is broken or missing.

OTC - ASK DOCTOR SECTION

If symptoms persist for more than 7 days or worsen, contact a licensed health care provider.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or nursing, seek the advice of a licensed health care provider before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep all medications out of the reach of children.

QUESTIONS?

OTC - QUESTIONS SECTION

800.624.9659

PRINCIPAL DISPLAY PANEL - 500 Tablet Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-8081-01

Hyland's®

#12

Silicea 6X

Skin Eruptions,
Brittle Hair and Nails

500 TABLETS

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-8081-1SILICEA500 in 1 BOTTLE, PLASTICTABLET5004
54973-8081-2SILICEA1000 in 1 BOTTLE, PLASTICTABLET10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-8081SILICEA (SILICON DIOXIDE) TABLET [HYLAND'S INC.]4Current NDC, Legacy NDC, 2 package rows20221220_86da31ff-b39a-4ac2-92e5-810f6d8888e6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
ACACIAINACTIVE INGREDIENT5C5403N26O1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-808154973-8081-1, 54973-8081-2

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
ACACIA5C5403N26OIACT
LACTOSEJ2B2A4N98GIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
SILICEASILICON DIOXIDEHyland's Inc.86da31ff-b39a-4ac2-92e5-810f6d8888e62022-12-19WarningsExact identifier
ndc (package): 54973-8081-2
ndc (package): 54973-8081-1
ndc (product): 54973-8081
ndc11 (package): 54973808102
ndc11 (package): 54973808101
spl id: f03254bf-1190-17ba-e053-2a95a90a13bb
spl set id: 86da31ff-b39a-4ac2-92e5-810f6d8888e6

Reported adverse events (FAERS/openFDA)#

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