FDA.reportPublic FDA data

Flu-Tone

Manufacturer
Energetix Corporation
Effective date
2025-07-15
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:34:24

Label at a glance#

ProductFlu-Tone
Active ingredientCAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, AZADIRACHTA INDICA BARK, BAPTISIA TINCTORIA ROOT, BRYONIA ALBA ROOT, CROTALUS HORRIDUS HORRIDUS VENOM, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS ROOT, GINKGO, INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED), SUS SCROFA NASAL MUCOSA, PHYTOLACCA AMERICANA ROOT, PINUS SYLVESTRIS LEAFY TWIG, RANCID BEEF, SELENIUM, STILLINGIA SYLVATICA ROOT
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: 59.1 mL contains 4.34% of Anas barbariae 15C, 30C; Azadirachta 12X; Baptisia 4X; Bryonia 12X; Crotalus hor 15X; Echinacea 4X; Eupatorium perf 30X, 30C; Ferrum phos 12X; Gelsemium 6X; Ginkgo 4X; Influenzinum 30X, 30C; Mucosa nas 9X, 12X, 6C; Phytolacca 4X; Pinus syl 9X; Pyrogenium 30X, 30C; Selenium 12X; Stillingia 4X.

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

INDICATIONS & USAGE SECTION

Uses

Temporary relief of flu-like symptoms such as aches, fever, nausea, cough, fatigue.

WARNINGS SECTION

Warnings

In case of overdose, get medical help or call a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Take 30 drops orally twice daily or as directed by a healthcare professional.
Consult a physician for use in children under 12 years of age or if symptoms worsen or persist.

OTHER SAFETY INFORMATION

Other information

  • Store at room temperature out of direct sunlight.
  • Do not use if neck wrap is broken or missing.
  • Shake well before use.

INACTIVE INGREDIENT SECTION

Inactive ingredients Alcohol, Vegetable Glycerin, Purified Water.

OTC - QUESTIONS SECTION

Distributed by Energetix Corp
Dahlonega, GA 30533
Questions? Comments?
800.990.7085

www.energetix.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

energetix

Flu-Tone
Homeopathic Remedy

Flu-like symptoms such as aches, fever,

nausea, cough, fatigue.

2 fl oz (59.1 mL) / 15% Alcohol

Flu-Tone r09-24 03021Flu-Tone r09-24 03021

OTC - PURPOSE SECTION

Purpose Temporary relief of flu-like symptoms such as aches, fever, nausea, cough, fatigue.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64578-0136-1Flu-Tone59 mL in 1 PACKAGELIQUID597

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64578-013664578-0136-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATERN2HC612GYACTIB
AZADIRACHTA INDICA BARKG580B439YIACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
FERRUM PHOSPHORICUM91GQH8I5F7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
GINKGO19FUJ2C58TACTIB
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)Q3P251C5MTACTIB
INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)2ZSC17SIJ6ACTIB
INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED)8V4458342XACTIB
INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED)B93BQX9789ACTIB
SUS SCROFA NASAL MUCOSAID3Z1X61WYACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
PINUS SYLVESTRIS LEAFY TWIGQ1RGP4UB73ACTIB
RANCID BEEF29SUH5R3HUACTIB
SELENIUMH6241UJ22BACTIB
STILLINGIA SYLVATICA ROOTQBR70R4FBKACTIB

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
Flu-ToneANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, AZADIRACHTA INDICA, BAPTISIA TINCTORIA, BRYONIA (ALBA), CROTALUS HORRIDUS, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, GINKGO BILOBA, INFLUENZINUM, MUCOSA NASALIS SUIS, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, PYROGENIUM, SELENIUM METALLICUM, STILLINGIA SYLVATICAEnergetix Corporation05038fb6-033f-4e5f-a476-07e15160a03d2025-07-15WarningsExact identifier
ndc (package): 64578-0136-1
ndc (product): 64578-0136
ndc11 (package): 64578013601
spl id: 2786f3a9-d2a7-a945-e063-6294a90a1700
spl set id: 05038fb6-033f-4e5f-a476-07e15160a03d

Reported adverse events (FAERS/openFDA)#

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