BioTox Hep
DRUG FACTS:
9da1043b-ceea-4613-a2f9-56f7d23455bb
HUMAN OTC DRUG LABEL
May 28, 2025
The Wellness Center for Research and Education, Inc.
DUNS: 832363993
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cochlearia Armoracia, Chelidonium Majus, Arsenicum Album, Hepar Suis, Spleen (Suis), Thymus (Suis), Hepatitis C Nosode, Hepatitis A Nosode, Hepatitis B Nosode
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (11)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL DISPLAY:
Dr. Theresa Dale's
NDC 50181-0055-1
Homeopathic
BioTox
Hep
1 fl oz (30 ml)
INDICATIONS & USAGE SECTION
INDICATIONS:
Fatigue, fever, cough, flu-like symptoms, virus, pain, swelling, and stiffness of limbs.
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
Cochlearia Armoracia 3X, Chelidonium Majus 3X, 6X, 8X, Arsenicum Album 6X, 8X, 12X, 30C, Hepar Suis 8X, 12X 30C, Spleen (Suis) 8X, 30C, Thymus (Suis) 8X, 1LM, Hepatitis C Nosode 17X, 30C, 60C, 1M, Hepatitis A Nosode 17X, 30C, 3LM, Hepatitis B Nosode 32X, 30C, 3LM.
OTC - PURPOSE SECTION
INDICATIONS:
Fatigue, fever, cough, flu-like symptoms, virus, pain, swelling, and stiffness of limbs.
WARNINGS SECTION
WARNINGS:
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF CHILDREN:
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS:
5 drops 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.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS:
Demineralized Water, 25% Ethanol
OTC - QUESTIONS SECTION
QUESTIONS:
MFD FOR:
The Wellness Center for
Research and Education, Inc.
1237 S. Victoria Ave. Suite 169
Oxnard CA 93035
1-866-962-6484