FDA.reportPublic FDA data

Amoebatox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2021-06-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:43:25

Label at a glance#

ProductAmoebatox
Active ingredientTRITICUM AESTIVUM WHOLE, BAPTISIA TINCTORIA ROOT, CAPSICUM, ALPINE STRAWBERRY, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, QUASSIA AMARA WOOD, SENNA LEAF, GOLDENSEAL, PODOPHYLLUM, BEEF LIVER, SUS SCROFA PANCREAS, BOS TAURUS SPLEEN, ATROPA BELLADONNA, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM SPORE, NITRIC ACID, STRYCHNOS NUX-VOMICA SEED, ENTAMOEBA HISTOLYTICA, GIARDIA LAMBLIA
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Triticum Aestivum MT, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Fragaria Vesca 3X, Hamamelis Virginiana 3X, Quassia Amara 3X, Senna 3X, Hydrastis Canadensis 5X, Podophyllum Peltatum 6X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Giardia Lamblia 15C, 30C, 100C, Entamoeba Histolytica 18C, 30C, 100C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of symptoms of diarrhea, mucousy stools, intestinal bloating.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care 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 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

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms of diarrhea, mucousy stools, intestinal bloating.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Cajuput (Leaf) Essential Oil, Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

AMOEBATOX

HOMEOPATHIC

1 FL OZ (30 ml)

AmoebatoxAmoebatox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0517-12021-06-16C16284748780-1ba0f9c33-46e9-a910-e053-dadaa90a0b85Drug Facts:
43857-0517-12021-01-29C16284748780-1ba0f9c33-46e9-a910-e053-dadaa90a0b85Drug Facts:

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-051743857-0517-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRITICUM AESTIVUM WHOLE3C3Y389JBUACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
CAPSICUM00UK7646FGACTIB
ALPINE STRAWBERRYCG6IX3GCMUACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
QUASSIA AMARA WOODS5249Q85HWACTIB
SENNA LEAFAK7JF626KXACTIB
GOLDENSEALZW3Z11D0JVACTIB
PODOPHYLLUM2S713A4VP3ACTIB
BEEF LIVERW8N8R55022ACTIB
SUS SCROFA PANCREAS9Y3J3362RYACTIB
BOS TAURUS SPLEEN190Q9MB3U3ACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
NITRIC ACID411VRN1TV4ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
ENTAMOEBA HISTOLYTICA2XC2HJ478WACTIB
GIARDIA LAMBLIA89IEJ09R73ACTIB
MELALEUCA CAJUPUTI LEAF OIL5O59RMR6DUIACT
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
f5ad6638-3a2d-45a7-99c9-dfb398ed7a02c360c0df-78c3-492b-8119-58e28934ad922021-06-16WarningsExact identifier
spl id: f5ad6638-3a2d-45a7-99c9-dfb398ed7a02
spl set id: c360c0df-78c3-492b-8119-58e28934ad92

Reported adverse events (FAERS/openFDA)#

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