FDA.reportPublic FDA data

Hepastat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2025-05-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:33:36

Label at a glance#

ProductHepastat
Active ingredientBETA VULGARIS WHOLE, SILYBUM MARIANUM SEED, TARAXACUM OFFICINALE, CHOLESTEROL, BOS TAURUS BILE, CHELIDONIUM MAJUS WHOLE, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
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 7 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): 19.90% of Chelidonium Majus 12X, Lycopodium Clavatum 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X; 0.10% of Beta Vulgaris 3X, Carduus Marianus 3X, Cholesterinum 6X, Fel Tauri 6X, Taraxacum Officinale 3X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve indigestion, flatulence, exhaustion, nausea and constipation.**

**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 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve indigestion, flatulence, exhaustion, nausea and constipation.**

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

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

HEPASTAT

1 fl. oz. (30 ml)

HepastatHepastat

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
44911-0070-12024-10-25C16284748780-1ba0f9c33-4f0d-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0070-12023-01-30C16284748780-1ba0f9c33-4f0d-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0070-12021-05-17C16284748780-1ba0f9c33-4f0d-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0070-12021-01-29C16284748780-1ba0f9c33-4f0d-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0070-1Hepastat30 mL in 1 BOTTLE, DROPPERLIQUID305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0070HEPASTAT (BETA VULGARIS, CARDUUS MARIANUS, TARAXACUM OFFICINALE, CHOLESTERINUM, FEL TAURI, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS) LIQUID [ENERGIQUE, INC.]5Current NDC, Legacy NDC, 1 package rows20250521_d75ab44f-49cb-4a90-9e92-42457c603319.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BETA VULGARISACTIVE INGREDIENT4G174V50511
BOS TAURUS BILEACTIVE INGREDIENTET3651ZLOU1
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN1
CHOLESTEROLACTIVE INGREDIENT97C5T2UQ7J1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4791
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
SILYBUM MARIANUM SEEDACTIVE INGREDIENTU946SH95EE1
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139191
TARAXACUM OFFICINALEACTIVE INGREDIENT39981FM3751
BETA VULGARISACTIVE MOIETY4G174V50511
BOS TAURUS BILEACTIVE MOIETYET3651ZLOU1
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN1
CHOLESTEROLACTIVE MOIETY97C5T2UQ7J1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4791
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
SILYBUM MARIANUM SEEDACTIVE MOIETYU946SH95EE1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139191
TARAXACUM OFFICINALEACTIVE MOIETY39981FM3751
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
44911-007044911-0070-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA VULGARIS WHOLE4G174V5051ACTIB
SILYBUM MARIANUM SEEDU946SH95EEACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
CHOLESTEROL97C5T2UQ7JACTIB
BOS TAURUS BILEET3651ZLOUACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
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
HepastatBETA VULGARIS, CARDUUS MARIANUS, TARAXACUM OFFICINALE, CHOLESTERINUM, FEL TAURI, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.d75ab44f-49cb-4a90-9e92-42457c6033192025-05-19WarningsExact identifier
ndc (package): 44911-0070-1
ndc (product): 44911-0070
ndc11 (package): 44911007001
spl id: c9b9fe1c-76c6-4d0b-849b-55b6b0946507
spl set id: d75ab44f-49cb-4a90-9e92-42457c603319

Reported adverse events (FAERS/openFDA)#

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