LIVER TONIC I- not applicable liquid

LIVER TONIC by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS:

Carduus Marianus 1X, Lycopodium Clavatum 1X, Taraxacum Officinale 1X, Chionanthus Virginica 3X, Quassia (Amara) 3X, Hepar Bovine 8X, 12X, 30X, 200X, Ceanothus Americanus 12X, Colocynthis 12X, Leptandra Virginica 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X, Teucrium Marum 12X  

INDICATIONS:

For temporary relief of sour, bitter taste after eating, fullness and soreness over the liver, coated tongue, flatulence, and diarrhea alternating with constipation.

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 sour, bitter taste after eating, fullness and soreness over the liver, coated tongue, flatulence, and diarrhea alternating with constipation.

INACTIVE INGREDIENTS:

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

LIVER TONIC I

2 FL OZ (60ml)

INGREDIENTS AND APPEARANCE

LIVER TONIC  I
not applicable liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0319
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	1 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	1 [hp_X]  in 1 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	1 [hp_X]  in 1 mL
CHIONANTHUS VIRGINICUS BARK (UNII: S9Y4B22U2E) (CHIONANTHUS VIRGINICUS BARK - UNII:S9Y4B22U2E)	CHIONANTHUS VIRGINICUS 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
BEEF LIVER (UNII: W8N8R55022) (BEEF LIVER - UNII:W8N8R55022)	BEEF LIVER	8 [hp_X]  in 1 mL
CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N)	CEANOTHUS AMERICANUS LEAF	12 [hp_X]  in 1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	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
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750)	SODIUM SULFATE	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
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
TEUCRIUM MARUM (UNII: 10464S0TAA) (TEUCRIUM MARUM - UNII:10464S0TAA)	TEUCRIUM MARUM	12 [hp_X]  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: 43857-0319-1	60 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/16/2014

Labeler - BioActive, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0319) , api manufacture(43857-0319) , label(43857-0319) , pack(43857-0319)