FDA.reportPublic FDA data

Liver Tonic

Manufacturer
Apotheca Company
Effective date
2023-05-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:31:50

Label at a glance#

ProductLiver Tonic I
Active ingredientSILYBUM MARIANUM SEED, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, CHIONANTHUS VIRGINICUS BARK, QUASSIA AMARA WOOD, CEANOTHUS AMERICANUS LEAF, CITRULLUS COLOCYNTHIS FRUIT PULP, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, TEUCRIUM MARUM, BEEF LIVER, CULVER'S ROOT
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:  Carduus marianus 1X, Chelidonium majus 1X, Taraxacum officinale 1X, Chionanthus virginica 3X, Quassia amara 3X, 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.

OTC - PURPOSE SECTION

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 SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:  Demineralized water, 25% Ethanol.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - QUESTIONS SECTION

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

LIVER TONIC I

2 FL OZ (60 ml)

Liver Tonic ILiver Tonic I

Liver Tonic ILiver Tonic I

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57520-0535-12023-05-04C16284748780-19d75b9cf-d3ee-f424-e053-dadaa90a57ceLiver Tonic I
57520-0535-12020-01-31C16284748780-19d75b9cf-d3ee-f424-e053-dadaa90a57ceLiver Tonic I

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BEEF LIVERACTIVE INGREDIENTW8N8R550221
CEANOTHUS AMERICANUS LEAFACTIVE INGREDIENT25B1Y14T8N1
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN1
CHIONANTHUS VIRGINICUS BARKACTIVE INGREDIENTS9Y4B22U2E1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE INGREDIENT23H32AOH171
CULVER'S ROOTACTIVE INGREDIENTM2O62YTN421
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
QUASSIA AMARA WOODACTIVE INGREDIENTS5249Q85HW1
SILYBUM MARIANUM SEEDACTIVE INGREDIENTU946SH95EE1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
TARAXACUM OFFICINALEACTIVE INGREDIENT39981FM3751
TEUCRIUM MARUMACTIVE INGREDIENT10464S0TAA1
BEEF LIVERACTIVE MOIETYW8N8R550221
CEANOTHUS AMERICANUS LEAFACTIVE MOIETY25B1Y14T8N1
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN1
CHIONANTHUS VIRGINICUS BARKACTIVE MOIETYS9Y4B22U2E1
CITRULLUS COLOCYNTHIS FRUIT PULPACTIVE MOIETY23H32AOH171
CULVER'S ROOTACTIVE MOIETYM2O62YTN421
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
QUASSIA AMARA WOODACTIVE MOIETYS5249Q85HW1
SILYBUM MARIANUM SEEDACTIVE MOIETYU946SH95EE1
SODIUM CATIONACTIVE MOIETYLYR4M0NH371
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
TARAXACUM OFFICINALEACTIVE MOIETY39981FM3751
TEUCRIUM MARUMACTIVE MOIETY10464S0TAA1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57520-053557520-0535-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILYBUM MARIANUM SEEDU946SH95EEACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
CHIONANTHUS VIRGINICUS BARKS9Y4B22U2EACTIB
QUASSIA AMARA WOODS5249Q85HWACTIB
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
TEUCRIUM MARUM10464S0TAAACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
BEEF LIVERW8N8R55022ACTIB
CULVER'S ROOTM2O62YTN42ACTIB

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 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
030f9626-c12f-41b9-8d04-e91c089c45b29dc608fb-9ee8-472d-b0e8-cef3c731bc8a2023-05-04WarningsExact identifier
spl id: 030f9626-c12f-41b9-8d04-e91c089c45b2
spl set id: 9dc608fb-9ee8-472d-b0e8-cef3c731bc8a

Reported adverse events (FAERS/openFDA)#

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