FDA.reportPublic FDA data

Hepapar

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-08-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:27:50

Label at a glance#

ProductHepapar
Active ingredientMILK THISTLE, CHELIDONIUM MAJUS WHOLE, TARAXACUM OFFICINALE, PEUMUS BOLDUS LEAF, PORK LIVER, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, DYSPHANIA AMBROSIOIDES WHOLE
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 12.46% of Boldo 6X, Chenopodium Anthelminticum 16X, Hepar Suis 6X, Lycopodium Clavatum 12X, Mercurius Solubilis 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X; 0.10% of Carduus Marianus 3X, Chelidonium Majus 3X, Taraxacum Officinale 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve abdominal bloating and 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 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

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 2 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve abdominal bloating and soreness and constipation alternating with diarrhea.

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

HEPAPAR

1 fl. oz. (30 ml)

HepaparHepapar

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
44911-0516-12024-08-26C16284748780-1ba0f9c33-2938-a910-e053-dadaa90a0b85Drug Facts:
44911-0516-12024-01-30C16284748780-1ba0f9c33-2938-a910-e053-dadaa90a0b85Drug Facts:
44911-0516-12022-03-09C16284748780-1ba0f9c33-2938-a910-e053-dadaa90a0b85Drug Facts:
44911-0516-12021-01-29C16284748780-1ba0f9c33-2938-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0516-1Hepapar30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0516HEPAPAR (CARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, BOLDO, HEPAR SUIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, CHENOPODIUM ANTHELMINTICUM) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20240828_9c670a50-16db-42a4-bc29-02818e27ea85.zip

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
44911-051644911-0516-1

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
MILK THISTLEU946SH95EEACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
PEUMUS BOLDUS LEAFQ4EWM09M3OACTIB
PORK LIVER6EC706HI7FACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
DYSPHANIA AMBROSIOIDES WHOLE4H5RSU087IACTIB
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
HepaparCARDUUS MARIANUS, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, BOLDO, HEPAR SUIS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, CHENOPODIUM ANTHELMINTICUMEnergique, Inc.9c670a50-16db-42a4-bc29-02818e27ea852024-08-26WarningsExact identifier
ndc (package): 44911-0516-1
ndc (product): 44911-0516
ndc11 (package): 44911051601
spl id: 8d8552df-3dfa-45ee-a686-94593c464dcf
spl set id: 9c670a50-16db-42a4-bc29-02818e27ea85

Reported adverse events (FAERS/openFDA)#

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