NDC 55714-4501 Muscle - Tendon

Aconitum Nap., Antimon. Tart., Arg. Nit., Arnica, Bryonia, Chamomilla, Chelidonium Majus, Cimicifuga, Eupatorium Perf., Hypericum, Nux Vom., Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Stramonium, Strychninum, Phytolacca, Symphytum

NDC Product Code 55714-4501

NDC Code: 55714-4501

Proprietary Name: Muscle - Tendon 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., Antimon. Tart., Arg. Nit., Arnica, Bryonia, Chamomilla, Chelidonium Majus, Cimicifuga, Eupatorium Perf., Hypericum, Nux Vom., Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Stramonium, Strychninum, Phytolacca, Symphytum 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.
    • 55714-4501 - Muscle - Tendon

NDC 55714-4501-1

Package Description: 28.35 g in 1 BOTTLE, GLASS

NDC 55714-4501-2

Package Description: 56.7 g in 1 BOTTLE, GLASS

NDC Product Information

Muscle - Tendon with NDC 55714-4501 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Muscle - Tendon is aconitum nap., antimon. tart., arg. nit., arnica, bryonia, chamomilla, chelidonium majus, cimicifuga, eupatorium perf., hypericum, nux vom., rhus toxicodendron, ruta, sarcolacticum ac., stramonium, strychninum, phytolacca, symphytum. The product's dosage form is pellet and is administered via oral form.

Labeler Name: Newton Laboratories, Inc.

Dosage Form: Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.

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.

Muscle - Tendon 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]/g
  • ANTIMONY POTASSIUM TARTRATE 20 [hp_X]/g
  • SILVER NITRATE 20 [hp_X]/g
  • ARNICA MONTANA 20 [hp_X]/g
  • BRYONIA ALBA ROOT 20 [hp_X]/g
  • MATRICARIA RECUTITA 20 [hp_X]/g
  • CHELIDONIUM MAJUS 20 [hp_X]/g
  • BLACK COHOSH 20 [hp_X]/g
  • EUPATORIUM PERFOLIATUM FLOWERING TOP 20 [hp_X]/g
  • HYPERICUM PERFORATUM 20 [hp_X]/g
  • STRYCHNOS NUX-VOMICA SEED 20 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 20 [hp_X]/g
  • RUTA GRAVEOLENS FLOWERING TOP 20 [hp_X]/g
  • LACTIC ACID, L- 20 [hp_X]/g
  • DATURA STRAMONIUM 20 [hp_X]/g
  • STRYCHNINE 20 [hp_X]/g
  • PHYTOLACCA AMERICANA ROOT 8 [hp_X]/g
  • COMFREY ROOT 8 [hp_X]/g

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.

  • SUCROSE (UNII: C151H8M554)

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 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.

Muscle - Tendon Product Label Images

Muscle - Tendon 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

Muscle - Tendon   Formulated for symptoms associated with tendinitis, carpal tunnel, myasthenia, myalgia, myotonia and other muscle or tendon disorders.

Dosage & Administration Section

Directions:  Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) as needed or as directed by a healthcare professional.  Under age 2, crush or dissolve pellets in purified water.

Active Ingredient Section

Aconitum nap. 20x, Antimon. tart. 20x, Arg. nit. 20x, Arnica 20x, Bryonia 20x, Chamomilla 20x, Chelidonium majus 20x, Cimicifuga 20x, Eupatorium perf. 20x, Hypericum 20x, Nux vom. 20x, Rhus toxicodendron 20x, Ruta 20x, Sarcolacticum ac. 20x, Stramonium 20x, Strychninum 20x, Chamomilla 8x, Phytolacca 8x, Ruta 8x, Symphytum 8x, Chamomilla 3x, Phytolacca 3x, Ruta 3x, Symphytum 3x.

Purpose Section

Formulated for symptoms associated with tendinitis, carpal tunnel, myasthenia, myalgia, myotonia and other muscle or tendon disorders.

Inactive Ingredient Section

Inactive Ingredients:  Gluten-free, non-GMO, beet-derived sucrose pellets.

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.

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