Genstat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2023-07-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:21:43

Label at a glance#

ProductGenstat
Active ingredientHORSE CHESTNUT, EQUISETUM HYEMALE WHOLE, FUMARIA OFFICINALIS FLOWERING TOP, CENTELLA ASIATICA WHOLE, OLIVE OIL, PASSIFLORA INCARNATA FLOWERING TOP, RIBES NIGRUM LEAF, SOLIDAGO VIRGAUREA FLOWERING TOP, ONONIS SPINOSA WHOLE
Label structure9 sections

Dosage and administration

4 to 5 droppersful in a glass of juice before breakfast.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in each drop): 11.11% of Aesculus Hippocastanum 6X, Equisetum Hyemale 6X, Fumaria Officinalis 6X, Hydrocotyle Asiatica 6X, Oleum Olea Europaea 6X, Ononis Spinosa 14C, Passiflora Incarnata 6X, Ribes Nigrum 7X, Solidago Virgaurea 6X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve symptoms associated with general toxicity, such as the sudden desire to urinate, weakness and fatigue, increased mucus leading to cough or hoarseness, abdominal bloating, constipation alternating with diarrhea, muscle stiffness, soreness and pain.**

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

WARNINGS:

WARNINGS SECTION

If pregnant or breastfeeding, 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

4 to 5 droppersful in a glass of juice before breakfast.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms associated with general toxicity, such as the sudden desire to urinate, weakness and fatigue, increased mucus leading to cough or hoarseness, abdominal bloating, constipation alternating with diarrhea, muscle stiffness, soreness and pain.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric acid, Demineralized water, Magnesium chloride, Potassium sorbate

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
GENSTAT
4 fl. oz. (120 ml)

GenstatGenstat

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0520-12023-07-12C16284748780-1ba0f9c33-2935-a910-e053-dadaa90a0b85Drug Facts:
44911-0520-12023-01-30C16284748780-1ba0f9c33-2935-a910-e053-dadaa90a0b85Drug Facts:
44911-0520-12021-05-25C16284748780-1ba0f9c33-2935-a910-e053-dadaa90a0b85Drug Facts:
44911-0520-12021-01-29C16284748780-1ba0f9c33-2935-a910-e053-dadaa90a0b85Drug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0520-1Genstat120 mL in 1 BOTTLE, DROPPERLIQUID1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0520GENSTAT (AESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, HYDROCOTYLE ASIATICA, OLEUM OLEA EUROPAEA, PASSIFLORA INCARNATA, RIBES NIGRUM, SOLIDAGO VIRGAUREA, ONONIS SPINOSA) LIQUID [ENERGIQUE, INC.]3Current NDC, Legacy NDC, 1 package rows20230713_492f311e-f4b5-442d-adc3-d022e58b185e.zip

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
44911-052044911-0520-1

Ingredients#

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

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

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
GenstatAESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, HYDROCOTYLE ASIATICA, OLEUM OLEA EUROPAEA, PASSIFLORA INCARNATA, RIBES NIGRUM, SOLIDAGO VIRGAUREA, ONONIS SPINOSAEnergique, Inc.492f311e-f4b5-442d-adc3-d022e58b185e2023-07-12WarningsExact identifier
ndc (package): 44911-0520-1
ndc (product): 44911-0520
ndc11 (package): 44911052001
spl id: aacaa774-0e0d-49da-85f0-023aeb49f339
spl set id: 492f311e-f4b5-442d-adc3-d022e58b185e

Reported adverse events (FAERS/openFDA)#

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