AMOEBATOX- triticum aestivum, baptisia tinctoria, capsicum annuum, frasera caroliniensis, hamamelis virginiana, hydrastis canadensis, quassia amara, senna, hepar bovine, pancreas suis, spleen (bovine), belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, amoeba axis, giardia lamblia liquid
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Triticum Aestivum MT, Baptisia Tinctoria 3X, Capsicum Annuum 3X, Frasera Caroliniensis 3X, Hamamelis Virginiana 3X, Hydrastis Canadensis 3X, Quassia Amara 3X, Senna 3X, Hepar Bovine 8X, Pancreas Suis 8X, Spleen (Bovine) 8X, Belladonna 12X, Cinchona Officinalis 12X, Lycopodium Clavatum 12X, Nitricum Acidum 12X, Nux Vomica 12X, Amoeba Axis 15C, 30C, 100C, Giardia Lamblia 15C, 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) oil, Demineralized water, 25% Ethanol

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

AMOEBATOX

1 FL OZ (30 ml)

Amoebatox

AMOEBATOX
triticum aestivum, baptisia tinctoria, capsicum annuum, frasera caroliniensis, hamamelis virginiana, hydrastis canadensis, quassia amara, senna, hepar bovine, pancreas suis, spleen (bovine), belladonna, cinchona officinalis, lycopodium clavatum, nitricum acidum, nux vomica, amoeba axis, giardia lamblia liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0374
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
FRASERA CAROLINIENSIS ROOT (UNII: 1JX35YMF5T) (FRASERA CAROLINIENSIS ROOT - UNII:1JX35YMF5T)	FRASERA CAROLINIENSIS ROOT	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
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	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
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 WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J)	ATROPA BELLADONNA WHOLE	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
AMOEBA PROTEUS (UNII: APR291GFYV) (AMOEBA PROTEUS - UNII:APR291GFYV)	AMOEBA PROTEUS	15 [hp_C] in 1 mL
GIARDIA LAMBLIA (UNII: 89IEJ09R73) (GIARDIA LAMBLIA - UNII:89IEJ09R73)	GIARDIA LAMBLIA	15 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CAJUPUT OIL (UNII: J3TO6BUQ37)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0374-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	07/30/2015	08/26/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/28/2015	08/26/2020

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0374) , api manufacture(43857-0374) , label(43857-0374) , pack(43857-0374)

Revised: 9/2016

Document Id: b3eba646-b09e-4e70-b700-256f0dc4df7a

Set id: 8c769a4a-2f96-4fe5-bfaf-56bc9647cf41

Version: 2

Effective Time: 20160922

BioActive Nutritional, Inc.