FDA.reportPublic FDA data

Hepataplex

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-03-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:37:55

Label at a glance#

ProductHepataplex
Active ingredientPEUMUS BOLDUS LEAF, MILK THISTLE, CHELIDONIUM MAJUS WHOLE, ARCTIUM LAPPA ROOT, PETROSELINUM CRISPUM WHOLE, TARAXACUM OFFICINALE, GLUTATHIONE, PORK LIVER, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
Label structure9 sections

Indications and uses

For temporary relief of abdominal bloating, soreness, and constipation alternating with diarrhea.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Boldo 3X, Carduus Marianus 3X, Chelidonium Majus 3X, Glutathione 6X, Hepar Suis 6X, Lappa Major 3X, Lycopodium Clavatum 12X, Nux Vomica 12X, Petroselinum Sativum 3X, Phosphorus 12X, Taraxacum Officinale 3X.

PURPOSE:

OTC - PURPOSE SECTION

Boldo - constipation,** Carduus Marianus – stomach pain,** Chelidonium Majus - gas,** Glutathione - constipation,** Hepar Suis – stomach cramps,** Lappa Major - nausea,** Lycopodium Clavatum - fever,** Nux Vomica – stomach cramps,** Petroselinum Sativum - fatigue,** Phosphorus – abdominal pain,** Taraxacum Officinale – flatulence**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

For temporary relief of abdominal bloating, soreness, and constipation alternating with diarrhea.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 a cool, dry place.

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

• 10 drops orally, 3 times a day or as directed by a health care professional.

• Consult a health care professional for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActive Nutritional

HEPATAPLEX

HOMEOPATHIC

1 fl. oz. (30 mL)

HepataplexHepataplex

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184341091GTIN-13: 0210184341091
EAN-13: 0210184341091
GTIN-12: 210184341091
UPC-A: 210184341091
GTIN storage (14 digits): 00210184341091		BANI44 Hepataplex 11-11-25.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0627-12024-08-29C16284748780-11030e365-143a-111a-e063-dadaa90a10e2DRUG FACTS:
43857-0627-12024-01-30C16284748780-11030e365-143a-111a-e063-dadaa90a10e2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0627-1Hepataplex30 mL in 1 BOTTLE, DROPPERLIQUID304

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-062743857-0627-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEUMUS BOLDUS LEAFQ4EWM09M3OACTIB
MILK THISTLEU946SH95EEACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
PETROSELINUM CRISPUM WHOLE1WZA4Y92EXACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
GLUTATHIONEGAN16C9B8OACTIB
PORK LIVER6EC706HI7FACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
HepataplexBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, LAPPA MAJOR, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORUSBioActive Nutritional, Inc.455040e3-becd-4b31-a524-fc1dc54537402026-03-10WarningsExact identifier
ndc (package): 43857-0627-1
ndc (product): 43857-0627
ndc11 (package): 43857062701
spl id: 5ae7720b-a36e-48ea-9ce7-4e3e5a545c64
spl set id: 455040e3-becd-4b31-a524-fc1dc5453740

Reported adverse events (FAERS/openFDA)#

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