NDC 43857-0490 Apizelen

Alfalfa, Aralia Quinquefolia, Avena Sativa, Beta Vulgaris, Calendula Officinalis, Chelidonium Majus, Echinacea (angustifolia), Natrum Muriaticum, Oxalis Acetosella, Paloondo, Phytolacca Decandra, Trifolium Pratense, Urtica Dioica, Viscum Album, Cobalt Acetate, Cobalt Gluconate, Copper Gluconate, Cuprum Aceticum, Glutathione, Magnesium Gluconicum Dihydricum, Ganoderma Lucidum, Ubidecarenonum, Argentum Metallicum, Germanium Metallicum

NDC Product Code 43857-0490

NDC Code: 43857-0490

Proprietary Name: Apizelen 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: Alfalfa, Aralia Quinquefolia, Avena Sativa, Beta Vulgaris, Calendula Officinalis, Chelidonium Majus, Echinacea (angustifolia), Natrum Muriaticum, Oxalis Acetosella, Paloondo, Phytolacca Decandra, Trifolium Pratense, Urtica Dioica, Viscum Album, Cobalt Acetate, Cobalt Gluconate, Copper Gluconate, Cuprum Aceticum, Glutathione, Magnesium Gluconicum Dihydricum, Ganoderma Lucidum, Ubidecarenonum, Argentum Metallicum, Germanium Metallicum 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.
    • 43857-0490 - Apizelen

NDC 43857-0490-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Apizelen with NDC 43857-0490 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Apizelen is alfalfa, aralia quinquefolia, avena sativa, beta vulgaris, calendula officinalis, chelidonium majus, echinacea (angustifolia), natrum muriaticum, oxalis acetosella, paloondo, phytolacca decandra, trifolium pratense, urtica dioica, viscum album, cobalt acetate, cobalt gluconate, copper gluconate, cuprum aceticum, glutathione, magnesium gluconicum dihydricum, ganoderma lucidum, ubidecarenonum, argentum metallicum, germanium metallicum. 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.

Apizelen 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.

  • ALFALFA 2 [hp_C]/mL
  • AMERICAN GINSENG 2 [hp_C]/mL
  • AVENA SATIVA FLOWERING TOP 2 [hp_C]/mL
  • BETA VULGARIS 2 [hp_C]/mL
  • CALENDULA OFFICINALIS FLOWERING TOP 2 [hp_C]/mL
  • CHELIDONIUM MAJUS 2 [hp_C]/mL
  • ECHINACEA ANGUSTIFOLIA 2 [hp_C]/mL
  • SODIUM CHLORIDE 2 [hp_C]/mL
  • OXALIS ACETOSELLA LEAF 2 [hp_C]/mL
  • LARREA TRIDENTATA LEAF 2 [hp_C]/mL
  • PHYTOLACCA AMERICANA ROOT 2 [hp_C]/mL
  • TRIFOLIUM PRATENSE FLOWER 2 [hp_C]/mL
  • URTICA DIOICA 2 [hp_C]/mL
  • VISCUM ALBUM FRUITING TOP 2 [hp_C]/mL
  • COBALTOUS ACETATE 3 [hp_C]/mL
  • COBALTOUS GLUCONATE 3 [hp_C]/mL
  • COPPER GLUCONATE 3 [hp_C]/mL
  • CUPRIC ACETATE 3 [hp_C]/mL
  • GLUTATHIONE 3 [hp_C]/mL
  • MAGNESIUM GLUCONATE 3 [hp_C]/mL
  • REISHI 5 [hp_C]/mL
  • UBIDECARENONE 5 [hp_C]/mL
  • SILVER 8 [hp_C]/mL
  • GERMANIUM 8 [hp_C]/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.

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: 09-10-2018 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: 12-31-2019 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.

Apizelen Product Label Images

Apizelen 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:

Alfalfa 1C, Aralia Quinquefolia 2C, Avena Sativa 1C, Beta Vulgaris 2C, Calendula Officinalis 2C, Chelidonium Majus 1C, Echinacea (Angustifolia) 2C, Natrum Muriaticum 2C, Oxalis Acetosella 2C, Paloondo 2C, Phytolacca Decandra 2C, Trifolium Pratense 2C, Urtica Dioica 2C, Viscum Album 2C, Cobalt Acetate 3C, Cobalt Gluconate 3C, Copper Gluconate 3C, Cuprum Aceticum 3C, Glutathione 3C, Magnesium Gluconicum Dihydricum 3C, Ganoderma Lucidum 5C, Ubidecarenonum 5C, Argentum Metallicum 8C, Germanium Metallicum 8C.

Indications:

For temporary relief of fatigue, indigestion, and flatulent colic.

For temporary relief of fatigue, indigestion, and flatulent colic.

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 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

Package Label Display:

BIOActive NutritionalAPIZELENHOMEOPATHIC1 FL OZ (30 ml)

* Please review the disclaimer below.

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