LIVER TONIC II- boldo, carduus marianus, curcuma longa, echinacea (angustifolia), taraxacum officinale magnesia phosphorica, gallbladder (bovine), hepar bovine, ammi visnaga, atropinum sulphuricum, chelidonium majus, leptandra virginica, podophyllinum 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:

Boldo MT, Carduus Marianus MT, Curcuma Longa MT, Echinacea (Angustifolia) MT, Taraxacum Officinale MT, Magnesia Phosphorica 8X, Gallbladder (bovine) 8X, 12X, 30X, 200X, Hepar Bovine 8X, 12X, 30X, 200X, Ammi Visnaga 12X, Atropinum Sulphuricum 12X, Chelidonium Majus 12X, Leptandra Virginica 12X, Podophyllinum 12C.

INDICATIONS:

For temporary relief of bitter taste in mouth, nausea, pain through the stomach to the back and right shoulder, and abdominal distention with liver region painful.

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 bitter taste in mouth, nausea, pain through the stomach to the back and right shoulder, and abdominal distention with liver region painful.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

LIVER TONIC II

HOMEOPATHIC

2 FL OZ (60 ml)

Liver Tonic II

LIVER TONIC II
boldo, carduus marianus, curcuma longa, echinacea (angustifolia), taraxacum officinale magnesia phosphorica, gallbladder (bovine), hepar bovine, ammi visnaga, atropinum sulphuricum, chelidonium majus, leptandra virginica, podophyllinum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0328
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O)	PEUMUS BOLDUS LEAF	1 [hp_X] in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	1 [hp_X] in 1 mL
TURMERIC (UNII: 856YO1Z64F) (TURMERIC - UNII:856YO1Z64F)	TURMERIC	1 [hp_X] in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_X] in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	1 [hp_X] in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X] in 1 mL
BOS TAURUS GALLBLADDER (UNII: 9901V1E867) (BOS TAURUS GALLBLADDER - UNII:9901V1E867)	BOS TAURUS GALLBLADDER	8 [hp_X] in 1 mL
BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022)	BEEF LIVER	8 [hp_X] in 1 mL
AMMI VISNAGA FRUIT (UNII: 3UN285QN0C) (AMMI VISNAGA FRUIT - UNII:3UN285QN0C)	AMMI VISNAGA FRUIT	12 [hp_X] in 1 mL
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	12 [hp_X] in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	12 [hp_X] in 1 mL
VERONICASTRUM VIRGINICUM ROOT (UNII: M2O62YTN42) (CULVER'S ROOT - UNII:M2O62YTN42)	VERONICASTRUM VIRGINICUM ROOT	12 [hp_X] in 1 mL
PODOPHYLLUM RESIN (UNII: 16902YVY2B) (PODOPHYLLUM RESIN - UNII:16902YVY2B)	PODOPHYLLUM RESIN	12 [hp_C] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0328-1	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/10/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/25/2014

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0328) , api manufacture(43857-0328) , label(43857-0328) , pack(43857-0328)