NDC 64578-0136 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, Mucosa Nasalis Suis, Phytolacca Decandra, Pinus Sylvestris, Pyrogenium, Selenium Metallicum, Stillingia Sylvatica

  1. Labeler Index
  2. Energetix Corp
  3. NDC: 64578-0136 Flu-tone

NDC Product Code 64578-0136

NDC CODE: 64578-0136

Proprietary Name: Flu-tone What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: 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, Mucosa Nasalis Suis, Phytolacca Decandra, Pinus Sylvestris, Pyrogenium, Selenium Metallicum, Stillingia Sylvatica What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 64578-0136-1

Package Description: 59 mL in 1 PACKAGE

NDC Product Information

Flu-tone with NDC 64578-0136 is a a human over the counter drug product labeled by Energetix Corp. The generic name of Flu-tone is 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, mucosa nasalis suis, phytolacca decandra, pinus sylvestris, pyrogenium, selenium metallicum, stillingia sylvatica. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Energetix Corp

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Flu-tone Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
  • CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE 15 [hp_C]/mL
  • AZADIRACHTA INDICA BARK 12 [hp_X]/mL
  • BAPTISIA TINCTORIA ROOT 4 [hp_X]/mL
  • BRYONIA ALBA ROOT 12 [hp_X]/mL
  • CROTALUS HORRIDUS HORRIDUS VENOM 15 [hp_X]/mL
  • ECHINACEA ANGUSTIFOLIA 4 [hp_X]/mL
  • EUPATORIUM PERFOLIATUM FLOWERING TOP 30 [hp_X]/mL
  • FERRUM PHOSPHORICUM 12 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/mL
  • GINKGO 4 [hp_X]/mL
  • INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 30 [hp_X]/mL
  • INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 30 [hp_X]/mL
  • INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) 30 [hp_X]/mL
  • INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) 30 [hp_X]/mL
  • SUS SCROFA NASAL MUCOSA 9 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 4 [hp_X]/mL
  • PINUS SYLVESTRIS LEAFY TWIG 9 [hp_X]/mL
  • RANCID BEEF 30 [hp_X]/mL
  • SELENIUM 12 [hp_X]/mL
  • STILLINGIA SYLVATICA ROOT 4 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Energetix Corp
Labeler Code: 64578
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Start Marketing Date: 11-01-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Flu-tone Product Label Images

Flu-tone Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

59.1 mL contains 7.14% of Anas barbariae, Hepatis et cordis extractum 15C, 30C; Baptisia tinctoria 4X; Echinacea (Angustifolia) 4X; Eupatorium Perfoliatum 30C; Ginkgo biloba 4X; Influenzinum 30X, 30C; Mucosa nasalis suis 6C; Phytolacca decandra 4X; Pyrogenium 30C; Selenium metallicum 12X; Stillingia sylvatica 4X; 0.71% of Azadirachta indica 12X; Bryonia (Alba)12X; Crotalus horridus 15X; Eupatorium Perfoliatum 30X; Ferrum phosphoricum 12X; Gelsemium sempervirens 6X; Mucosa nasalis suis 9X, 12X; Pinus sylvestris 9X; Pyrogenium 30X.

Purpose:

Temporary relief of flu-like symptoms such as aches, fever, nausea, cough, fatigue.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 InformationStore at room temperature 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-like symptoms such as aches, fever, nausea, cough, fatigue.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Inactive Ingredients:

15% Ethyl Alcohol, Glycerin, Purified Water.

Questions:

Distributed by Energetix CorpDahlonega, GA 30533Questions? Comments?800.990.7085www.goenergetix.com

Package Label Display:

EnergetixFlu-ToneHomeopathic Remedyflu-like symptoms such as aches, fever,nausea, cough, fatigue.2 fl oz (59.1 mL)

* Please review the disclaimer below.