NDC 55714-4552 Exhaustion Chronic Fatigue

Aconitum Nap., Adrenalinum, Aralia Quinquefolia, Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Cinchona, Iodium, Kali Carb., Kali Iod.,lachesis,lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca, Alcohol

NDC Product Code 55714-4552

NDC Code: 55714-4552

Proprietary Name: Exhaustion Chronic Fatigue 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: Aconitum Nap., Adrenalinum, Aralia Quinquefolia, Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Cinchona, Iodium, Kali Carb., Kali Iod.,lachesis,lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea, Gingko, Phytolacca, Alcohol 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

  • 55714 - Newton Laboratories, Inc.
    • 55714-4552 - Exhaustion Chronic Fatigue

NDC 55714-4552-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC 55714-4552-2

Package Description: 59.14 mL in 1 BOTTLE, GLASS

NDC Product Information

Exhaustion Chronic Fatigue with NDC 55714-4552 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Exhaustion Chronic Fatigue is aconitum nap., adrenalinum, aralia quinquefolia, arnica, arsenicum alb., baptisia, bryonia, cantharis, chelidonium majus, cinchona, iodium, kali carb., kali iod.,lachesis,lycopodium, lycopus virginicus, nat. mur., nux vom., phosphorus, pulsatilla, rhus toxicodendron, sabal, thyroidinum, echinacea, gingko, phytolacca, alcohol. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Newton Laboratories, 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 Prescription 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.

Exhaustion Chronic Fatigue 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.

  • ACONITUM NAPELLUS 20 [hp_X]/mL
  • EPINEPHRINE 20 [hp_X]/mL
  • AMERICAN GINSENG 20 [hp_X]/mL
  • ARNICA MONTANA 20 [hp_X]/mL
  • ARSENIC TRIOXIDE 20 [hp_X]/mL
  • BAPTISIA TINCTORIA 20 [hp_X]/mL
  • BRYONIA ALBA ROOT 20 [hp_X]/mL
  • LYTTA VESICATORIA 20 [hp_X]/mL
  • CHELIDONIUM MAJUS 20 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 20 [hp_X]/mL
  • IODINE 20 [hp_X]/mL
  • POTASSIUM CARBONATE 20 [hp_X]/mL
  • POTASSIUM IODIDE 20 [hp_X]/mL
  • LACHESIS MUTA VENOM 20 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 20 [hp_X]/mL
  • LYCOPUS VIRGINICUS 20 [hp_X]/mL
  • SODIUM CHLORIDE 20 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 20 [hp_X]/mL
  • PHOSPHORUS 20 [hp_X]/mL
  • PULSATILLA VULGARIS 20 [hp_X]/mL
  • TOXICODENDRON PUBESCENS LEAF 20 [hp_X]/mL
  • SAW PALMETTO 20 [hp_X]/mL
  • THYROID, UNSPECIFIED 20 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 8 [hp_X]/mL
  • GINKGO 8 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 8 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • GINKGO 3 [hp_X]/mL
  • PHYTOLACCA AMERICANA ROOT 3 [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.

  • 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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Plant Proteins - [CS]
  • Seed Storage Proteins - [CS]
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • Adrenergic beta-Agonists - [MoA] (Mechanism of Action)
  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • beta-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • Catecholamine - [EPC] (Established Pharmacologic Class)
  • Catecholamines - [CS]

Product Labeler Information

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

Labeler Name: Newton Laboratories, Inc.
Labeler Code: 55714
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: 06-01-2011 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.

Exhaustion Chronic Fatigue Product Label Images

Exhaustion Chronic Fatigue 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

Product Name & Indications Section

Exhaustion~Chronic Fatigue  Formulated for symptoms associated with severe fatigue, Epstein-Barr, Chronic Fatigue Syndrome, adrenal exhaustion and other related conditions.

Direction Section

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

Active Ingredient Section

Aconitum nap. 20x, Adrenalinum 20x, Aralia quinquefolia 20x, Arnica 20x, Arsenicum alb. 20x, Baptisia 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Cinchona 20x, Iodium 20x, Kali carb. 20x, Kali iod. 20x, Lachesis 20x, Lycopodium 20x, Lycopus virginicus 20x, Nat. mur. 20x, Nux vom. 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sabal 20x, Thyroidinum 20x, Echinacea 8x, Gingko 8x, Phytolacca 8x, Echinacea 3x, Gingko 3x, Phytolacca 3x.

Purpose Section

Formulated for symptoms associated with severe fatigue, Epstein-Barr, Chronic Fatigue Syndrome, adrenal exhaustion and other related conditions.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

Questions? Section

Www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 -Conyers, GA 30012Questions?  1.800.448.7256

Warnings Section

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

Otc - Pregnancy Or Breast Feeding Section

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children.

* Please review the disclaimer below.

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