FDA.reportPublic FDA data

Liver Tonic

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-04-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:26:50

Label at a glance#

ProductLiver Tonic III
Active ingredientMILK THISTLE, CHELIDONIUM MAJUS WHOLE, TARAXACUM OFFICINALE, CHIONANTHUS VIRGINICUS BARK, QUASSIA AMARA WOOD, CALCIUM SULFIDE, BEEF LIVER, CEANOTHUS AMERICANUS LEAF, CITRULLUS COLOCYNTHIS FRUIT PULP, VERONICASTRUM VIRGINICUM ROOT, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, TEUCRIUM MARUM WHOLE, HEPATITIS A VIRUS, HEPATITIS B VIRUS, HEPATITIS C VIRUS
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Carduus Marianus 1X, Chelidonium Majus 1X, Taraxacum Officinale 1X, Chionanthus Virginica 3X, Quassia Amara 3X, Hepar Sulphuris Calcareum 8X, Hepar Bovinum 8X, 12X, 30X, 200X, Ceanothus Americanus 12X, Colocynthis 12X, Leptandra Virginica 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X, Teucrium Marum 12X, Hepatitis A 30X, 200X, Hepatitis B 30X, 200X, Hepatitis C 30X, 200X.

INDICATIONS:

OTC - PURPOSE SECTION

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

WARNINGS:

WARNINGS SECTION

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS:

INDICATIONS & USAGE SECTION

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

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

LIVER TONIC III

HOMEOPATHIC

2 FL OZ (60 ml)

Liver Tonic IIILiver Tonic III

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0107-12024-05-03C16284748780-1f386c649-faf5-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0107-12023-01-30C16284748780-1f386c649-faf5-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0107-1Liver TonicIII60 mL in 1 BOTTLE, DROPPERLIQUID606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0107LIVER TONIC III (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, CHIONANTHUS VIRGINICA, QUASSIA AMARA, HEPAR SULPHURIS CALCAREUM, HEPAR BOVINUM, CEANOTHUS AMERICANUS, COLOCYNTHIS, LEPTANDRA VIRGINICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, TEUCRIUM MARUM, HEPATITIS A, HEPATITIS B, HEPATITIS C) LIQUID [BIOACTIVE NUTRITIONAL, INC.]6Current NDC, Legacy NDC, 1 package rows20240504_2a8d1506-04ed-45a7-805e-d08cdab010ee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BEEF LIVERACTIVE INGREDIENTW8N8R550222
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q2
CEANOTHUS AMERICANUS LEAFACTIVE INGREDIENT25B1Y14T8N2
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN2
CHIONANTHUS VIRGINICUS BARKACTIVE INGREDIENTS9Y4B22U2E2
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH172
HEPATITIS A VIRUSACTIVE INGREDIENTG54MT8V18G2
HEPATITIS B VIRUSACTIVE INGREDIENT77H9EM77P72
HEPATITIS C VIRUSACTIVE INGREDIENTQI564152832
MILK THISTLEACTIVE INGREDIENTU946SH95EE2
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W2
QUASSIA AMARA WOODACTIVE INGREDIENTS5249Q85HW2
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J2
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139192
TARAXACUM OFFICINALEACTIVE INGREDIENT39981FM3752
TEUCRIUM MARUMACTIVE INGREDIENT10464S0TAA2
VERONICASTRUM VIRGINICUM ROOTACTIVE INGREDIENTM2O62YTN422
BEEF LIVERACTIVE MOIETYW8N8R550222
CALCIUM SULFIDEACTIVE MOIETY1MBW07J51Q2
CEANOTHUS AMERICANUS LEAFACTIVE MOIETY25B1Y14T8N2
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN2
CHIONANTHUS VIRGINICUS BARKACTIVE MOIETYS9Y4B22U2E2
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH172
CULVER'S ROOTACTIVE MOIETYM2O62YTN422
HEPATITIS A VIRUSACTIVE MOIETYG54MT8V18G2
HEPATITIS B VIRUSACTIVE MOIETY77H9EM77P72
HEPATITIS C VIRUSACTIVE MOIETYQI564152832
MILK THISTLEACTIVE MOIETYU946SH95EE2
PHOSPHORUSACTIVE MOIETY27YLU75U4W2
QUASSIA AMARA WOODACTIVE MOIETYS5249Q85HW2
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7502
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139192
TARAXACUM OFFICINALEACTIVE MOIETY39981FM3752
TEUCRIUM MARUMACTIVE MOIETY10464S0TAA2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-010743857-0107-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
MILK THISTLEU946SH95EEACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
CHIONANTHUS VIRGINICUS BARKS9Y4B22U2EACTIB
QUASSIA AMARA WOODS5249Q85HWACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
BEEF LIVERW8N8R55022ACTIB
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
VERONICASTRUM VIRGINICUM ROOTM2O62YTN42ACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
TEUCRIUM MARUM WHOLE10464S0TAAACTIB
HEPATITIS A VIRUSG54MT8V18GACTIB
HEPATITIS B VIRUS77H9EM77P7ACTIB
HEPATITIS C VIRUSQI56415283ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Liver Tonic IIICARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, CHIONANTHUS VIRGINICA, QUASSIA AMARA, HEPAR SULPHURIS CALCAREUM, HEPAR BOVINUM, CEANOTHUS AMERICANUS, COLOCYNTHIS, LEPTANDRA VIRGINICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, TEUCRIUM MARUM, HEPATITIS A, HEPATITIS B, HEPATITIS CBioActive Nutritional, Inc.2a8d1506-04ed-45a7-805e-d08cdab010ee2024-04-19WarningsExact identifier
ndc (package): 43857-0107-1
ndc (product): 43857-0107
ndc11 (package): 43857010701
spl id: 942c6ce9-8255-4c85-bd4d-58c87eb074de
spl set id: 2a8d1506-04ed-45a7-805e-d08cdab010ee

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.