FDA.reportPublic FDA data

BioTox P

Manufacturer
The Wellness Center For Research and Education | Apotheca Company
Effective date
2025-05-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:37:25

Label at a glance#

ProductBioTox P
Active ingredientHUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED
Label structure9 sections

Dosage and administration

5 drops three times daily (under tongue), 5 days per week until symptoms improve, then 5 drops 3 times daily for 3 days per week until symptoms abate. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Pertussinum 15C, 30C, 60C, 200C.

INDICATIONS:

OTC - PURPOSE SECTION

Whooping cough, pertussis, and other spasmodic coughs and homeoprophylaxis.

WARNINGS:

WARNINGS SECTION

If you are pregnant or breastfeeding, ask a health professional before using this product.

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.

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 three times daily (under tongue), 5 days per week until symptoms improve, then 5 drops 3 times daily for 3 days per week until symptoms abate. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

Whooping cough, pertussis, and other spasmodic coughs and homeoprophylaxis.

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, Suite 169

Oxnard, CA 93035  1-866-962-6484

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Theresa Dale's

NDC 50181-0057-1

Homeopathic

BioTox

P

1 fl oz (30 ml)

BioTox PBioTox P

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
50181-005750181-0057-1

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
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTEDU364V64HUNACTIB
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
087e1953-bc1f-40b3-b925-bfe330ef00aabd1a67b8-035d-4a3e-b74f-9b63de30c8342025-05-30WarningsExact identifier
spl id: 087e1953-bc1f-40b3-b925-bfe330ef00aa
spl set id: bd1a67b8-035d-4a3e-b74f-9b63de30c834

Reported adverse events (FAERS/openFDA)#

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