AMOEBATOX (triticum aestivum, baptisia tinctoria, capsicum annuum, fragaria vesca, hamamelis virginiana, quassia amara, senna, hydrastis canadensis, podophyllum peltatum, hepar bovine, pancreas suis, spleen- bovine, belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, giardia lamblia, entamoeba histolytica liquid

Amoebatox by

Drug Labeling and Warnings

Amoebatox by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

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:

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

WARNINGS:

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:

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

DIRECTIONS:

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

INDICATIONS:

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

INACTIVE INGREDIENTS:

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

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

AMOEBATOX

HOMEOPATHIC

1 FL OZ (30 ml)

INGREDIENTS AND APPEARANCE

AMOEBATOX 
triticum aestivum, baptisia tinctoria, capsicum annuum, fragaria vesca, hamamelis virginiana, quassia amara, senna, hydrastis canadensis, podophyllum peltatum, hepar bovine, pancreas suis, spleen (bovine), belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, giardia lamblia, entamoeba histolytica liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0517
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRITICUM AESTIVUM WHOLE (UNII: 3C3Y389JBU) (TRITICUM AESTIVUM WHOLE - UNII:3C3Y389JBU)	TRITICUM AESTIVUM WHOLE	1 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	3 [hp_X]  in 1 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	3 [hp_X]  in 1 mL
ALPINE STRAWBERRY (UNII: CG6IX3GCMU) (ALPINE STRAWBERRY - UNII:CG6IX3GCMU)	ALPINE STRAWBERRY	3 [hp_X]  in 1 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	3 [hp_X]  in 1 mL
QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW)	QUASSIA AMARA WOOD	3 [hp_X]  in 1 mL
SENNA LEAF (UNII: AK7JF626KX) (SENNA LEAF - UNII:AK7JF626KX)	SENNA LEAF	3 [hp_X]  in 1 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	5 [hp_X]  in 1 mL
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3)	PODOPHYLLUM	6 [hp_X]  in 1 mL
BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022)	BEEF LIVER	8 [hp_X]  in 1 mL
SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY)	SUS SCROFA PANCREAS	8 [hp_X]  in 1 mL
BOS TAURUS SPLEEN (UNII: 190Q9MB3U3) (BOS TAURUS SPLEEN - UNII:190Q9MB3U3)	BOS TAURUS SPLEEN	8 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	12 [hp_X]  in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	12 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 1 mL
NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4)	NITRIC ACID	12 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X]  in 1 mL
ENTAMOEBA HISTOLYTICA (UNII: 2XC2HJ478W) (ENTAMOEBA HISTOLYTICA - UNII:2XC2HJ478W)	ENTAMOEBA HISTOLYTICA	15 [hp_C]  in 1 mL
GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73)	GIARDIA LAMBLIA	18 [hp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MELALEUCA CAJUPUTI LEAF OIL (UNII: 5O59RMR6DU)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0517-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/06/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0517) , api manufacture(43857-0517) , label(43857-0517) , pack(43857-0517)