NDC 43857-0441 Hayfever Tonic

Echinacea Purpurea, Hydrastis Canadensis, Eupatorium Perfoliatum, Verbascum Thapsus, Alfalfa, American Elm, Platanus, Fraxinus Americana, Fagus Sylvatica, Flos, Black Walnut, Salix Nigra, Negundo, Eastern Cottonwood, False Ragweed, Giant Ragweed, Solidago Virguarea, Kentucky Bluegrass, Orchard Grass, Red Birch, Trifolium Pratense, Red Oak, Redtop Grass, Hickory, Rumex Acetosa, Ambrosia Artemesiafolia, Timothy Grass, Western Ragweed, Rumex Crispus, Ailanthus Glandulosus, Allium Cepa, Aurum Muriaticum

NDC Product Code 43857-0441

NDC CODE: 43857-0441

Proprietary Name: Hayfever Tonic 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: Echinacea Purpurea, Hydrastis Canadensis, Eupatorium Perfoliatum, Verbascum Thapsus, Alfalfa, American Elm, Platanus, Fraxinus Americana, Fagus Sylvatica, Flos, Black Walnut, Salix Nigra, Negundo, Eastern Cottonwood, False Ragweed, Giant Ragweed, Solidago Virguarea, Kentucky Bluegrass, Orchard Grass, Red Birch, Trifolium Pratense, Red Oak, Redtop Grass, Hickory, Rumex Acetosa, Ambrosia Artemesiafolia, Timothy Grass, Western Ragweed, Rumex Crispus, Ailanthus Glandulosus, Allium Cepa, Aurum Muriaticum 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

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0441-1

Package Description: 60 mL in 1 BOTTLE, DROPPER

NDC Product Information

Hayfever Tonic with NDC 43857-0441 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Hayfever Tonic is echinacea purpurea, hydrastis canadensis, eupatorium perfoliatum, verbascum thapsus, alfalfa, american elm, platanus, fraxinus americana, fagus sylvatica, flos, black walnut, salix nigra, negundo, eastern cottonwood, false ragweed, giant ragweed, solidago virguarea, kentucky bluegrass, orchard grass, red birch, trifolium pratense, red oak, redtop grass, hickory, rumex acetosa, ambrosia artemesiafolia, timothy grass, western ragweed, rumex crispus, ailanthus glandulosus, allium cepa, aurum muriaticum. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc.

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.

Hayfever Tonic 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.

  • ECHINACEA PURPUREA 1 [hp_X]/mL
  • EUPATORIUM PERFOLIATUM FLOWERING TOP 1 [hp_X]/mL
  • VERBASCUM THAPSUS 3 [hp_X]/mL
  • GOLDENSEAL 5 [hp_X]/mL
  • ALFALFA 9 [hp_X]/mL
  • ULMUS AMERICANA POLLEN 9 [hp_X]/mL
  • ACER PSEUDOPLATANUS POLLEN 9 [hp_X]/mL
  • FRAXINUS AMERICANA POLLEN 9 [hp_X]/mL
  • FAGUS SYLVATICA FLOWERING TOP 9 [hp_X]/mL
  • JUGLANS NIGRA POLLEN 9 [hp_X]/mL
  • SALIX NIGRA POLLEN 9 [hp_X]/mL
  • ACER NEGUNDO POLLEN 9 [hp_X]/mL
  • POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN 9 [hp_X]/mL
  • AMBROSIA ACANTHICARPA POLLEN 9 [hp_X]/mL
  • AMBROSIA TRIFIDA POLLEN 9 [hp_X]/mL
  • SOLIDAGO VIRGAUREA POLLEN 9 [hp_X]/mL
  • POA PRATENSIS POLLEN 9 [hp_X]/mL
  • DACTYLIS GLOMERATA POLLEN 9 [hp_X]/mL
  • BETULA OCCIDENTALIS POLLEN 9 [hp_X]/mL
  • TRIFOLIUM PRATENSE POLLEN 9 [hp_X]/mL
  • QUERCUS RUBRA POLLEN 9 [hp_X]/mL
  • AGROSTIS GIGANTEA POLLEN 9 [hp_X]/mL
  • CARYA OVATA POLLEN 9 [hp_X]/mL
  • RUMEX ACETOSELLA POLLEN 9 [hp_X]/mL
  • AMBROSIA ARTEMISIIFOLIA POLLEN 9 [hp_X]/mL
  • PHLEUM PRATENSE POLLEN 9 [hp_X]/mL
  • AMBROSIA PSILOSTACHYA POLLEN 9 [hp_X]/mL
  • RUMEX CRISPUS POLLEN 9 [hp_X]/mL
  • AILANTHUS ALTISSIMA POLLEN 12 [hp_X]/mL
  • ONION 12 [hp_X]/mL
  • GOLD TRICHLORIDE 12 [hp_X]/mL
  • CAMPHOR (NATURAL) 12 [hp_X]/mL
  • IPECAC 12 [hp_X]/mL
  • POTASSIUM DICHROMATE 12 [hp_X]/mL
  • SOLIDAGO VIRGAUREA FLOWERING TOP 12 [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)

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.
  • 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: Bioactive Nutritional, Inc.
Labeler Code: 43857
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: 05-17-2017 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.

Hayfever Tonic Product Label Images

Hayfever Tonic 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:

Echinacea Purpurea MT, 3X, Eupatorium Perfoliatum MT, 12X, Verbascum Thapsus 3X, Hydrastis Canadensis 5X, Alfalfa 9X, 12X, 30X, American Elm 9X, 12X, 30X, Platanus 9X, 12X, 30X, Fraxinus Americana 9X, 12X, 30X, Fagus Sylvatica 9X, 12X, 30X, Flos, Black Walnut 9X, 12X, 30X, Salix Nigra 9X, 12X, 30X, Negundo 9X, 12X, 30X, Eastern Cottonwood 9X, 12X, 30X, False Ragweed 9X, 12X, 30X, Giant Ragweed 9X, 12X, 30X, Solidago Virguarea 9X, 12X, 30X, Kentucky Bluegrass 9X, 12X, 30X, Orchard Grass 9X, 12X, 30X, Red Birch 9X, 12X, 30X, Trifolium Pratense 9X, 12X, 30X, Red Oak 9X, 12X, 30X, Redtop Grass 9X, 12X, 30X, Hickory 9X, 12X, 30X, Rumex Acetosa 9X, 12X, 30X, Ambrosia Artemesiafolia 9X, 12X, 30X, Timothy Grass 9X, 12X, 30X, Western Ragweed 9X, 12X, 30X, Rumex Crispus 9X, 12X, 30X, Ailanthus Glandulosus 12X,, Allium Cepa 12X, Ambrosia Artemesiafolia 12X, Aurum Muriaticum 12X, Camphora 12X, Ipecacuanha 12X, Kali Bichromicum 12X, Solidago Virgaurea 12X.

Indications:

For temporary relief of coryza, sneezing, water discharge. Stuffed up feeling of nose and head. Eyes red with much burning. Hoarseness and cough with soreness in the chest.

For temporary relief of coryza, sneezing, water discharge. Stuffed up feeling of nose and head. Eyes red with much burning. Hoarseness and cough with soreness in the chest.

Warnings:

If pregnant or breast-feeding, ask a health care 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:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Questions:

Distributed by:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935bioactivenutritional.com*For a complete list of Pollen Allersode contact BioActive Nutritional, Inc.

Package Label Display:

BIOActive NutritionalHAYFEVER TONICHOMEOPATHIC2 FL OZ (60 ml)

* Please review the disclaimer below.