Liver Tonic II

Drug Labeling and Warnings

Drug Details [pdf]

LIVER TONIC II- boldo, carduus marianus, curcuma longa, echinacea, 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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Liver Tonic II

ACTIVE INGREDIENTS: Boldo 1X, Carduus Marianus 1X, Curcuma Longa 1X, Echinacea 1X, Taraxacum Officinale 1X, Magnesia Phosphorica 8X, Gallbladder (Bovinum) 8X, 12X, 30X, 200X, Hepar Bovinum 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 a cool, dry place.

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

INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

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.

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd,

Melbourne, FL 32935

BioActive Homeopathic

LIVER TONICII

2 FL OZ (60 ml)

​

LIVER TONIC  II
boldo, carduus marianus, curcuma longa, echinacea, 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: 43857-0056
Route of Administration	Oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) (PEUMUS BOLDUS LEAF - UNII:Q4EWM09M3O)	PEUMUS BOLDUS LEAF	1 [hp_X]  in 1 mL
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	1 [hp_X]  in 1 mL
TURMERIC (UNII: 856YO1Z64F) (TURMERIC - UNII:856YO1Z64F)	TURMERIC	1 [hp_X]  in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	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) (VERONICASTRUM VIRGINICUM ROOT - UNII:M2O62YTN42)	VERONICASTRUM VIRGINICUM ROOT	12 [hp_X]  in 1 mL
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3)	PODOPHYLLUM	12 [hp_C]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0056-1	60 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/17/2012	06/18/2019

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0056) , api manufacture(43857-0056) , label(43857-0056) , pack(43857-0056)

Revised: 6/2015

Document Id: 216b4182-9a8d-4982-8b2c-79d9f14747e7

Set id: 83cbd66d-e446-49ed-89ca-b73073938f70

Version: 3

Effective Time: 20150609