FDA.reportPublic FDA data

Systemistat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2023-04-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:20:58

Label at a glance#

ProductSystemistat
Active ingredientBERBERIS VULGARIS ROOT BARK, CHELIDONIUM MAJUS WHOLE, ARCTIUM LAPPA ROOT, GOLDENSEAL, CALCIUM SULFIDE, LYCOPODIUM CLAVATUM SPORE, SULFUR, OYSTER SHELL CALCIUM CARBONATE, CRUDE, MERCURIUS SOLUBILIS, THUJA OCCIDENTALIS LEAFY TWIG
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): 14.24% of Calcarea Carbonica 30X, Hepar Sulphuris Calcareum 12X, Hydrastis Canadensis 5X, Lycopodium Clavatum 12X, Mercurius Solubilis 30X, Sulphur 12X, Thuja Occidentalis 30X; 0.10% of Berberis Vulgaris 3X, Chelidonium Majus 3X, Lappa Major 3X.

PURPOSE:

OTC - PURPOSE SECTION

May temporarily relieve symptons of fatigue, brain fog, sinus congestion, lymphatic congestion, poor digestion or eczema with itching.**

**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.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptons of fatigue, brain fog, sinus congestion, lymphatic congestion, poor digestion or eczema with itching.**

**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

HOMEPATHIC REMEDY

SYSTEMISTAT

1 fl. oz. (30 ml)

SYSTEMISTATSYSTEMISTAT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0449-12022-03-15C16284748780-1d6a99b39-fa03-a426-e053-dadaa90af4c2DRUG FACTS:
44911-0449-12022-01-28C16284748780-1d6a99b39-fa03-a426-e053-dadaa90af4c2DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0449-1Systemistat30 mL in 1 BOTTLE, DROPPERLIQUID304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0449SYSTEMISTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA OCCIDENTALIS) LIQUID [ENERGIQUE, INC.]4Current NDC, Legacy NDC, 1 package rows20230422_0d8aa575-3fae-4828-8827-d2561672a91e.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-044944911-0449-1

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
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CHELIDONIUM MAJUS WHOLE7E889U5RNNACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
GOLDENSEALZW3Z11D0JVACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SULFUR70FD1KFU70ACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
MERCURIUS SOLUBILIS324Y4038G2ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
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
SystemistatBERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA OCCIDENTALISEnergique, Inc.0d8aa575-3fae-4828-8827-d2561672a91e2023-04-21WarningsExact identifier
ndc (package): 44911-0449-1
ndc (product): 44911-0449
ndc11 (package): 44911044901
spl id: babfa6e6-4ea6-4937-af61-795cc3cb257e
spl set id: 0d8aa575-3fae-4828-8827-d2561672a91e

Reported adverse events (FAERS/openFDA)#

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