FLU-TONE (anas barbariae, hepatis et cordis extractum, azadirachta indica, baptisia tinctoria, bryonia (alba), crotalus horridus, echinacea (angustifolia), eupatorium perfoliatum, ferrum phosphoricum, gelsemium sempervirens, ginkgo biloba, influenzinum- 2015-2016, mucosa nasalis suis, phytolacca decandra, pinus sylvestris, pyrogenium, selenium metallicum, stillingia sylvatica liquid

Flu-Tone by

Drug Labeling and Warnings

Flu-Tone by is a Homeopathic medication manufactured, distributed, or labeled by Energetix Corp, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Anas Barbariae, Hepatis Et Cordis Extractum 15C, 30C; Azadirachta Indica 12X; Baptisia Tinctoria 4X; Bryonia (Alba)12X; Crotalus Horridus 15X; Echinacea (Angustifolia) 4X; Eupatorium Perfoliatum 30X, 30C; Ferrum Phosphoricum 12X; Gelsemium Sempervirens 6X; Ginkgo Biloba 4X; Influenzinum 30X, 30C; Mucosa Nasalis Suis 9X, 12X, 6C; Phytolacca Decandra 4X; Pinus Sylvestris 9X; Pyrogenium 30X, 30C; Selenium Metallicum 12X; Stillingia Sylvatica 4X.

PURPOSE:

Temporary relief of flu symptoms (early, mid-course, or recovery) such as aches, fever, chills, nausea, cough, fatigue, diarrhea.

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.

Keep out of reach of children.

Other Information

Store in cool, dry place out of direct sunlight.

Do not use if neck wrap is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

DIRECTIONS:

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.

USES:

Temporary relief of flu symptoms (early, mid-course, or recovery) such as aches, fever, chills, nausea, cough, fatigue, diarrhea.

INACTIVE INGREDIENTS:

Purified Water, Glycerin, 15% Ethyl Alcohol

QUESTIONS:

Distributed by

Energetix Corp

Dahlonega, GA 30533

Questions? 800.990.7085

PACKAGE LABEL DISPLAY:

energetix

Flu-Tone

Homeopathic Remedy

Flu symptoms (early, mid-course, or recovery)

such as aches, fever, chills, nausea, cough,

fatigue, diarrhea.

DIN-HM 80048285

2 fl oz (59.1 mL)

INGREDIENTS AND APPEARANCE

FLU-TONE 
anas barbariae, hepatis et cordis extractum, azadirachta indica, baptisia tinctoria, bryonia (alba), crotalus horridus, echinacea (angustifolia), eupatorium perfoliatum, ferrum phosphoricum, gelsemium sempervirens, ginkgo biloba, influenzinum (2015-2016), mucosa nasalis suis, phytolacca decandra, pinus sylvestris, pyrogenium, selenium metallicum, stillingia sylvatica liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64578-0126
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE (UNII: RN2HC612GY) (CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - UNII:RN2HC612GY)	CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE	15 [hp_X]  in 1 mL
AZADIRACHTA INDICA BARK (UNII: G580B439YI) (AZADIRACHTA INDICA BARK - UNII:G580B439YI)	AZADIRACHTA INDICA BARK	12 [hp_X]  in 1 mL
BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU)	BAPTISIA TINCTORIA ROOT	4 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	12 [hp_X]  in 1 mL
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956)	CROTALUS HORRIDUS HORRIDUS VENOM	15 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	4 [hp_X]  in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	30 [hp_X]  in 1 mL
FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERRUM PHOSPHORICUM	12 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]  in 1 mL
GINKGO (UNII: 19FUJ2C58T) (GINKGO - UNII:19FUJ2C58T)	GINKGO	4 [hp_X]  in 1 mL
INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: KFL1W6W9JB) (INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:KFL1W6W9JB)	INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	30 [hp_X]  in 1 mL
INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 80T3QS071U) (INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:80T3QS071U)	INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	30 [hp_X]  in 1 mL
INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: V3EC8AF8MF) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:V3EC8AF8MF)	INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	30 [hp_X]  in 1 mL
INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 445486QJCG) (INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:445486QJCG)	INFLUENZA A VIRUS A/SOUTH AUSTRALIA/55/2014 (H3N2) NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	30 [hp_X]  in 1 mL
INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 9VVQ21KI5Z) (INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:9VVQ21KI5Z)	INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	30 [hp_X]  in 1 mL
INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: 3W5C8YUT4D) (INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:3W5C8YUT4D)	INFLUENZA B VIRUS B/UTAH/9/2014 NEURAMINIDASE ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)	30 [hp_X]  in 1 mL
SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY)	SUS SCROFA NASAL MUCOSA	9 [hp_X]  in 1 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	4 [hp_X]  in 1 mL
PINUS SYLVESTRIS LEAFY TWIG (UNII: Q1RGP4UB73) (PINUS SYLVESTRIS LEAFY TWIG - UNII:Q1RGP4UB73)	PINUS SYLVESTRIS LEAFY TWIG	9 [hp_X]  in 1 mL
RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU)	RANCID BEEF	30 [hp_X]  in 1 mL
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	12 [hp_X]  in 1 mL
STILLINGIA SYLVATICA ROOT (UNII: QBR70R4FBK) (STILLINGIA SYLVATICA ROOT - UNII:QBR70R4FBK)	STILLINGIA SYLVATICA ROOT	4 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64578-0126-1	59.1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	03/01/2016	06/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2016	06/13/2021

Labeler - Energetix Corp (969572502)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(64578-0126) , api manufacture(64578-0126) , label(64578-0126) , pack(64578-0126)