FDA.reportPublic FDA data

Fatigue Stat CM

Manufacturer
Energique, Inc | Apotheca Company
Effective date
2024-05-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:26:54

Label at a glance#

ProductFatigue Stat CM
Active ingredientECHINACEA ANGUSTIFOLIA WHOLE, LOMATIUM DISSECTUM ROOT, TABEBUIA IMPETIGINOSA BARK, GOLDENSEAL, PHYTOLACCA AMERICANA ROOT, ARANEUS DIADEMATUS, IPECAC, IRIDIUM, LACHESIS MUTA VENOM, HYDROCHLORIC ACID, TOXICODENDRON PUBESCENS LEAF, HUMAN HERPESVIRUS 5
Label structure9 sections

Indications and uses

May temporarily relieve: • fever with digestive symptoms • muscular aches and pains** **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. • Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aranea Diadema 12X 9.06%, Cytomegalovirus Nosode 30X, 60X, 200X 9.06%, Hydrastis Canadensis 6X 90.6%, Ipecacuanha 12X 9.06%, Iridium Metallicum 12X 9.06%, Lachesis Mutus 12X 9.06%, Muriaticum Acidum 12X 9.06%, Phytolacca Decandra 6X 9.06%, Rhus Tox 12X 9.06%; Echinacea 3X 0.10%, Lomatium Dissectum 3X 0.10%, Tabebuia Impetiginosa 3X 0.10%.

PURPOSE:

OTC - PURPOSE SECTION

Aranea Diadema - chilliness,** Cytomegalovirus Nosode - fatigue,** Hydrastis Canadensis – loss of appetite,** Ipecacuanha - faintness,** Iridium Metallicum – weakness after illness,** Lachesis Mutus – weakness from heat,** Muriaticum Acidum - exhaustion,** Phytolacca Decandra – glandular swelling,** Rhus Tox – soreness, ** Echinacea – brain fog,** Lomatium Dissectum - malaise, Tabebuia Impetiginosa – indigestion**

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

USES:

INDICATIONS & USAGE SECTION

May temporarily relieve:

• fever with digestive symptoms

• muscular aches and pains**

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

WARNINGS:

WARNINGS SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days.

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.

• Consult a physician for use in children under 12 years of age.

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
FATIGUE STAT CM
1 fl. oz. (30 ml)

FATIGUE STAT CMFATIGUE STAT CM

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0609-12024-05-08C16284748780-1f386c649-cb22-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0609-12023-01-30C16284748780-1f386c649-cb22-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0609-1Fatigue Stat CM30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0609FATIGUE STAT CM (ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODE) LIQUID [ENERGIQUE, INC]2Current NDC, Legacy NDC, 1 package rows20240509_aebdb08b-48aa-46f2-930f-f98f5b06a604.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
44911-060944911-0609-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ECHINACEA ANGUSTIFOLIA WHOLEVB06AV5US8ACTIB
LOMATIUM DISSECTUM ROOT5329928G5NACTIB
TABEBUIA IMPETIGINOSA BARK6GLA1946WXACTIB
GOLDENSEALZW3Z11D0JVACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
ARANEUS DIADEMATUS6T6CO7R3Z5ACTIB
IPECAC62I3C8233LACTIB
IRIDIUM44448S9773ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
HYDROCHLORIC ACIDQTT17582CBACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
HUMAN HERPESVIRUS 57COI029E6KACTIB
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
Fatigue Stat CMECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODEEnergique, Incaebdb08b-48aa-46f2-930f-f98f5b06a6042024-05-08WarningsExact identifier
ndc (package): 44911-0609-1
ndc (product): 44911-0609
ndc11 (package): 44911060901
spl id: f3fa6899-99f8-4d07-8055-ce772e75ba44
spl set id: aebdb08b-48aa-46f2-930f-f98f5b06a604

Reported adverse events (FAERS/openFDA)#

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