LIVER TONIC 3- boldo, carduus marianus, taraxacum officinale, ceanothus americanus, quassia (amara), raphanus sativus, phosphorus, cholesterinum, benzinum, leptandra virginica, arsenicum album, germanium sesquioxide, adenosinum triphosphoricum dinatrum, manganum metallicum, colibacillinum cum natrum muriaticum, salmonella typhi liquid
Synergy Formulas, 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 1X, Carduus Marianus 1X, Taraxacum Officinale 1X, Ceanothus Americanus 2X, 6X, 12X, Quassia (Amara) 3X, Raphanus Sativus 3X, Phosphorus 4X, 6X, 12X, Cholesterinum 6X, Benzinum 6X, 12X, 24X, Leptandra Virginica 6X, 12X, 30X, Arsenicum Album 6X, 30X, Germanium Sesquioxide 8X, Adenosinum Triphosphoricum Dinatrum 8X, 12X, 24X, Manganum Metallicum 8X, 30X, Colibacillinum Cum Natrum Muriaticum 12X, 30X, Salmonella Typhi 30X

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:

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

If pregnant or breast-feeding, ask a health professional before use.

Do not use if tamper evident seal is broken or missing.

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:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322

PACKAGE LABEL DISPLAY:

Synergy Formulas

LIVER TONIC 3

HOMEOPATHIC

2 FL OZ (60 ml)

Liver Tonic 3

LIVER TONIC 3
boldo, carduus marianus, taraxacum officinale, ceanothus americanus, quassia (amara), raphanus sativus, phosphorus, cholesterinum, benzinum, leptandra virginica, arsenicum album, germanium sesquioxide, adenosinum triphosphoricum dinatrum, manganum metallicum, colibacillinum cum natrum muriaticum, salmonella typhi liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43772-0033
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
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	1 [hp_X] in 1 mL
CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N)	CEANOTHUS AMERICANUS LEAF	2 [hp_X] in 1 mL
QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW)	QUASSIA AMARA WOOD	3 [hp_X] in 1 mL
RADISH (UNII: EM5RP35463) (RADISH - UNII:EM5RP35463)	RADISH	3 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	4 [hp_X] in 1 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J)	CHOLESTEROL	6 [hp_X] in 1 mL
BENZENE (UNII: J64922108F) (BENZENE - UNII:J64922108F)	BENZENE	6 [hp_X] in 1 mL
VERONICASTRUM VIRGINICUM ROOT (UNII: M2O62YTN42) (CULVER'S ROOT - UNII:M2O62YTN42)	VERONICASTRUM VIRGINICUM ROOT	6 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	6 [hp_X] in 1 mL
GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T)	GERMANIUM SESQUIOXIDE	8 [hp_X] in 1 mL
ADENOSINE TRIPHOSPHATE DISODIUM (UNII: 5L51B4DR1G) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE)	ADENOSINE TRIPHOSPHATE DISODIUM	8 [hp_X] in 1 mL
MANGANESE (UNII: 42Z2K6ZL8P) (MANGANESE - UNII:42Z2K6ZL8P)	MANGANESE	8 [hp_X] in 1 mL
ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10)	ESCHERICHIA COLI	12 [hp_X] in 1 mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - UNII:760T5R8B3O)	SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI	30 [hp_X] 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:43772-0033-1	60 mL in 1 BOTTLE, DROPPER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/20/2014

Labeler - Synergy Formulas, Inc. (069579220)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43772-0033) , api manufacture(43772-0033) , label(43772-0033) , pack(43772-0033)