FDA.reportPublic FDA data

8 Fungal Yeast Infection

Manufacturer
21st Century Homeopathics, Inc | Apotheca Company
Effective date
2021-12-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:21:08

Label at a glance#

Product8 Fungal Yeast Infection
Active ingredientASTRAGALUS PROPINQUUS ROOT, BERBERIS VULGARIS ROOT BARK, ECHINACEA ANGUSTIFOLIA, GENTIANA LUTEA ROOT, GOLDENSEAL, PHYTOLACCA AMERICANA ROOT, CANDIDA ALBICANS, APIS MELLIFERA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAF
Label structure9 sections

Dosage and administration

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional. Consult a physician for use in children under 6 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Astragalus Membranaceus 3X, 30C, Berberis Vulgaris 3X, 30C, Echinacea (Angustifolia) 3X, 30C, Gentiana Lutea 3X, 30C, Hydrastis Canadensis 5X, 30C, Phytolacca Decandra 3X, 30C, Candida Albicans 12X, 30X, Apis Mellifica 30C, Calcarea Carbonica 30C, Lycopodium Clavatum 30C, Mercurius Solubilis 30C, Pulsatilla (Vulgaris) 30C, Sepia 30C, Thuja Occidentalis 30C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of flatulence, bloating and rhinitis. Remedy #8 supports detoxification due to mycotic infections.

WARNINGS:

WARNINGS SECTION

If symptoms persist or worsen, seek the advice of a healthcare professional.

Not recommended for pregnant or lactating women.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Tamper Seal: Sealed for your protection with a clear, full body seal. Do not use if seal is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional. Consult a physician for use in children under 6 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of flatulence, bloating and rhinitis. Remedy #8 supports detoxification due to mycotic infections.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric acid, Demineralized Water, Ethanol and Sodium benzoate.

QUESTIONS:

OTC - QUESTIONS SECTION

Manufactured for:

21st Century Homeopathics

Rosenberg, TX 77471 • (281) 344-0909

A subsidiary of Biotics Research Corporation

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

21ST CENTURY

HOMEOPATHICS

NDC #63972-015-01

HOMEOPATHIC REMEDY

#8

Fungal Yeast Infection

Water Based

Formula

4 fl. oz.

(120 ml)

#8 Fungal Yeast Infection#8 Fungal Yeast Infection

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63972-015-012021-12-23C16284748780-19d75b9cf-de92-f424-e053-dadaa90a57ceDrug Facts:
63972-015-012020-01-31C16284748780-19d75b9cf-de92-f424-e053-dadaa90a57ceDrug Facts:

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63972-01563972-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASTRAGALUS PROPINQUUS ROOT922OP8YUPFACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
GENTIANA LUTEA ROOTS72O3284MSACTIB
GOLDENSEALZW3Z11D0JVACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
APIS MELLIFERA7S82P3R43ZACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
THUJA OCCIDENTALIS LEAF0T0DQN8786ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
6b32708d-f657-4811-a04b-f31f877fc10773bb3224-f650-4e14-bf83-cfc4f8fe4e992021-12-23WarningsExact identifier
spl id: 6b32708d-f657-4811-a04b-f31f877fc107
spl set id: 73bb3224-f650-4e14-bf83-cfc4f8fe4e99

Reported adverse events (FAERS/openFDA)#

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