FDA.reportPublic FDA data

BIOTOX

Manufacturer
The Wellness Center for Research and Education, Inc. | Apotheca Company
Effective date
2025-05-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:37:21

Label at a glance#

ProductBIOTOX VI
Active ingredientHORSERADISH, BOS TAURUS SPLEEN, BOS TAURUS THYMUS, INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED), MYCOPLASMA PNEUMONIAE, HUMAN HERPESVIRUS 5, HUMAN PAPILLOMAVIRUS, HUMAN COXSACKIEVIRUS B1, HUMAN COXSACKIEVIRUS B4, STREPTOCOCCUS PNEUMONIAE, HUMAN BREAST TUMOR CELL
Label structure9 sections

Dosage and administration

5 drops orally 2 or 3 times per day, on an empty stomach, 5 days per week or until symptoms abate. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Cochlearia Armoracia 3X, Spleen (Bovine) 8X, Thymus Gland (Bovine) 8X, 1LM, Influenzinum (2019–2020) 10X, 12X, 30X, 30C, 100C, 200C, Mycoplasma Pneumoniae 12X, 15, 30X, 200X, Cytomegalovirus Nosode 12X, 15X, 30X, 30C, 3LM, Human Papilloma Nosode 12X, 18X, 30C, 100C, 200C, Coxsackie B1 Nosode 8C, 9C, 12C, 15C, 30C, Coxsackie B4 Nosode 8C, 9C, 12C, 15C, 30C, Pneumococcinum 30C, Carcinosin 30C, 200C, 3LM.

INDICATIONS:

OTC - PURPOSE SECTION

Fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling and stiffness of limbs.

WARNINGS:

WARNINGS SECTION

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

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

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

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

5 drops orally 2 or 3 times per day, on an empty stomach, 5 days per week or until symptoms abate.

Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Fatigue, fever, cough, flu-like symptoms, heart palpitations, virus, pain, swelling and stiffness of limbs.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

MFD FOR:

The Wellness Center for Research

and Education, Inc.

1237 S. Victoria Ave. Suite 169

Oxnard, CA 93035

1-866-962-6484

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Theresa Dale's

NDC: 50181-0062-1

Homeopathic

BioTox

Vi

1 fl oz (30 ml)

BioTox ViBioTox Vi

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50181-0062-12025-06-03C16284748780-1d6a99b39-d46c-a426-e053-dadaa90af4c2DRUG FACTS:
50181-0062-12022-01-28C16284748780-1d6a99b39-d46c-a426-e053-dadaa90af4c2DRUG FACTS:

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50181-006250181-0062-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
HORSERADISH8DS6G120HJACTIB
BOS TAURUS SPLEEN190Q9MB3U3ACTIB
BOS TAURUS THYMUS8XEJ88V2T8ACTIB
INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)XW4JB03TI5ACTIB
INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)3NZW5ND3D6ACTIB
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED)8V4458342XACTIB
MYCOPLASMA PNEUMONIAEJQE470FAD0ACTIB
HUMAN HERPESVIRUS 57COI029E6KACTIB
HUMAN PAPILLOMAVIRUS23CVL7WF4JACTIB
HUMAN COXSACKIEVIRUS B1ADL68M27WDACTIB
HUMAN COXSACKIEVIRUS B4FYF75V7FDYACTIB
STREPTOCOCCUS PNEUMONIAEBT6U234YR2ACTIB
HUMAN BREAST TUMOR CELLC62OO7VD9KACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML · Source PDF

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
49ea76e4-f96f-4627-a1af-6c39b0306d235bc05369-ad93-4e91-88bc-aaa6fc7c35ca2025-05-30WarningsExact identifier
spl id: 49ea76e4-f96f-4627-a1af-6c39b0306d23
spl set id: 5bc05369-ad93-4e91-88bc-aaa6fc7c35ca

Reported adverse events (FAERS/openFDA)#

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