FDA.reportPublic FDA data

Hepastat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2026-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:37:52

Label at a glance#

ProductHepastat
Active ingredientBETA VULGARIS WHOLE, MILK THISTLE, TARAXACUM OFFICINALE, CHOLESTEROL, CHOLINE HYDROXIDE, BOS TAURUS BILE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CHELIDONIUM MAJUS WHOLE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS
Label structure9 sections

Indications and uses

May temporarily relieve indigestion, flatulence, exhaustion, nausea, and constipation.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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): 14.20% of Calcarea Carbonica 12X, Chelidonium Majus 12X, Lycopodium Clavatum 12X, Mercurius Solubilis 12X, Natrum Sulphuricum 12X, Nux Vomica 12X, Phosphorus 12X; 0.10% of Beta Vulgaris 3X, Carduus Marianus 3X, Cholesterinum 6X, Cholinum 6X, Fel Tauri 6X, Taraxacum Officinale 3X.

PURPOSE:

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

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.

USES:

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.

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

HEPASTAT

1 fl. oz. (30 ml)

HEPASTATHEPASTAT

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363113701098GTIN-13: 0363113701098
EAN-13: 0363113701098
GTIN-12: 363113701098
UPC-A: 363113701098
GTIN storage (14 digits): 00363113701098		ENRG103 Hepastat 3-25-25.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0739-1Hepastat30 mL in 1 BOTTLE, DROPPERLIQUID301

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-073944911-0739-1

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
BETA VULGARIS WHOLE4G174V5051ACTIB
MILK THISTLEU946SH95EEACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
CHOLESTEROL97C5T2UQ7JACTIB
CHOLINE HYDROXIDE7THJ3EG9SYACTIB
BOS TAURUS BILEET3651ZLOUACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
SODIUM SULFATE0YPR65R21JACTIB
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
HepastatBETA VULGARIS, CARDUUS MARIANUS, TARAXACUM OFFICINALE, CHOLESTERINUM, CHOLINUM, FEL TAURI, CALCAREA CARBONICA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUSEnergique, Inc.d9ceea3f-c270-40fa-bf16-d83c683005ac2026-03-06WarningsExact identifier
ndc (package): 44911-0739-1
ndc (product): 44911-0739
ndc11 (package): 44911073901
spl id: 5ddeca81-a3fd-4573-ad62-f02e0db5160e
spl set id: d9ceea3f-c270-40fa-bf16-d83c683005ac

Reported adverse events (FAERS/openFDA)#

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