NDC 55714-4460 Nervousness - Anxiety

Aconitum Nap., Ambra, Anacardium Orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea Cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali Phos., Nux Vom., Sambucus Nig., Strychninum, Theridion, Valeriana, Passiflora

NDC Product Code 55714-4460

NDC Code: 55714-4460

Proprietary Name: Nervousness - Anxiety 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., Ambra, Anacardium Orientale, Arg.nit., Asafoetida, Bryonia, Chamomilla, Cimicifuga, Coffea Cruda, Cypripedium, Gelsemium, Hyoscyamus, Hypericum, Ignatia, Kali Phos., Nux Vom., Sambucus Nig., Strychninum, Theridion, Valeriana, Passiflora 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 55714-4460-1

Package Description: 29.57 mL in 1 BOTTLE, GLASS

NDC 55714-4460-2

Package Description: 59.14 mL in 1 BOTTLE, GLASS

NDC Product Information

Nervousness - Anxiety with NDC 55714-4460 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Nervousness - Anxiety is aconitum nap., ambra, anacardium orientale, arg.nit., asafoetida, bryonia, chamomilla, cimicifuga, coffea cruda, cypripedium, gelsemium, hyoscyamus, hypericum, ignatia, kali phos., nux vom., sambucus nig., strychninum, theridion, valeriana, passiflora. 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.

Nervousness - Anxiety 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
  • AMBERGRIS 20 [hp_X]/mL
  • SEMECARPUS ANACARDIUM JUICE 20 [hp_X]/mL
  • SILVER NITRATE 20 [hp_X]/mL
  • ASAFETIDA 20 [hp_X]/mL
  • BRYONIA ALBA ROOT 20 [hp_X]/mL
  • MATRICARIA RECUTITA 20 [hp_X]/mL
  • BLACK COHOSH 20 [hp_X]/mL
  • ARABICA COFFEE BEAN 20 [hp_X]/mL
  • CYPRIPEDIUM PARVIFOLUM ROOT 20 [hp_X]/mL
  • GELSEMIUM SEMPERVIRENS ROOT 20 [hp_X]/mL
  • HYOSCYAMUS NIGER 20 [hp_X]/mL
  • HYPERICUM PERFORATUM 20 [hp_X]/mL
  • STRYCHNOS IGNATII SEED 20 [hp_X]/mL
  • POTASSIUM PHOSPHATE, DIBASIC 20 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 20 [hp_X]/mL
  • SAMBUCUS NIGRA FLOWERING TOP 20 [hp_X]/mL
  • STRYCHNINE 20 [hp_X]/mL
  • THERIDION CURASSAVICUM 20 [hp_X]/mL
  • VALERIAN 20 [hp_X]/mL
  • PASSIFLORA INCARNATA FLOWERING TOP 8 [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.

  • Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Non-Standardized Plant Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Allergens - [CS]
  • Dietary Proteins - [CS]
  • Plant Proteins - [CS]
  • Seed Storage Proteins - [CS]
  • 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]

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.

Nervousness - Anxiety Product Label Images

Nervousness - Anxiety 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

Indications & Usage Section

Nervousness - Anxiety  Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks and other related conditions.

Dosage & Administration 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, Ambra 20x, Anacardium orientale 20x, Arg. nit. 20x, Asafoetida 20x, Bryonia 20x, Chamomilla 20x, Cimicifuga 20x, Coffea cruda 20x, Cypripedium 20x, Gelsemium 20x, Hyoscyamus 20x, Hypericum 20x, Ignatia 20x, Kali phos. 20x, Nux vom. 20x, Sambucus nig. 20x, Strychninum 20x, Theridion 20x, Valeriana 20x, Passiflora 8x, Valeriana 8x, Passiflora 3x, Valeriana 3x.

Purpose Section

Formulated for symptoms associated with generalized anxiety disorder, post-traumatic stress disorder, panic attacks 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.

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

Keep Out Of Reach Of Children Section

Keep out of reach of children

* Please review the disclaimer below.