NDC 55714-4503 Inflammation - Fever

Anthracinum, Pyrogenium, Aconitum Nap., Aloe, Apis Mel., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium Majus, Crotalus Horridus, Ferrum Phosphoricum, Gaultheria Procumbens, Hepar Sulph. Calc., Iodium, Lachesis, Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Veratrum Viride, Verbascum, Echinacea

NDC Product Code 55714-4503

NDC Code: 55714-4503

Proprietary Name: Inflammation - Fever 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: Anthracinum, Pyrogenium, Aconitum Nap., Aloe, Apis Mel., Arnica, Arsenicum Alb., Baptisia, Belladonna, Bryonia, Cantharis, Chelidonium Majus, Crotalus Horridus, Ferrum Phosphoricum, Gaultheria Procumbens, Hepar Sulph. Calc., Iodium, Lachesis, Nux Vom., Phosphorus, Pulsatilla, Rhus Toxicodendron, Veratrum Viride, Verbascum, Echinacea 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.
    • 55714-4503 - Inflammation - Fever

NDC 55714-4503-1

Package Description: 28.35 g in 1 BOTTLE, GLASS

NDC 55714-4503-2

Package Description: 56.7 g in 1 BOTTLE, GLASS

NDC Product Information

Inflammation - Fever with NDC 55714-4503 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Inflammation - Fever is anthracinum, pyrogenium, aconitum nap., aloe, apis mel., arnica, arsenicum alb., baptisia, belladonna, bryonia, cantharis, chelidonium majus, crotalus horridus, ferrum phosphoricum, gaultheria procumbens, hepar sulph. calc., iodium, lachesis, nux vom., phosphorus, pulsatilla, rhus toxicodendron, veratrum viride, verbascum, echinacea. 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.

Inflammation - Fever 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.

  • BACILLUS ANTHRACIS IMMUNOSERUM RABBIT 35 [hp_X]/g
  • RANCID BEEF 35 [hp_X]/g
  • ACONITUM NAPELLUS 20 [hp_X]/g
  • ALOE 20 [hp_X]/g
  • APIS MELLIFERA 20 [hp_X]/g
  • ARNICA MONTANA 20 [hp_X]/g
  • ARSENIC TRIOXIDE 20 [hp_X]/g
  • BAPTISIA TINCTORIA ROOT 20 [hp_X]/g
  • ATROPA BELLADONNA 20 [hp_X]/g
  • BRYONIA ALBA ROOT 20 [hp_X]/g
  • LYTTA VESICATORIA 20 [hp_X]/g
  • CHELIDONIUM MAJUS 20 [hp_X]/g
  • CROTALUS HORRIDUS HORRIDUS VENOM 20 [hp_X]/g
  • FERROSOFERRIC PHOSPHATE 20 [hp_X]/g
  • GAULTHERIA PROCUMBENS TOP 20 [hp_X]/g
  • CALCIUM SULFIDE 20 [hp_X]/g
  • IODINE 20 [hp_X]/g
  • LACHESIS MUTA VENOM 20 [hp_X]/g
  • STRYCHNOS NUX-VOMICA SEED 20 [hp_X]/g
  • PHOSPHORUS 20 [hp_X]/g
  • PULSATILLA VULGARIS 20 [hp_X]/g
  • TOXICODENDRON PUBESCENS LEAF 20 [hp_X]/g
  • VERATRUM VIRIDE ROOT 20 [hp_X]/g
  • VERBASCUM THAPSUS 20 [hp_X]/g
  • ECHINACEA, UNSPECIFIED 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.

  • Standardized Insect Venom 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]
  • Bee Venoms - [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.

Inflammation - Fever Product Label Images

Inflammation - Fever 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

Inflammation - Fever  Formulated for symptoms associated with abscesses, ulcerations, cellulitis, sepsis, fever and other inflammatory and infectious processes.

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

Anthracinum 35x, Pyrogenium 35x, Aconitum nap. 20x, Aloe 20x, Apis mel. 20x, Arnica 20x, Arsenicum alb. 20x, Baptisia 20x, Belladonna 20x, Bryonia 20x, Cantharis 20x, Chelidonium majus 20x, Crotalus horridus 20x, Ferrum phosphoricum 20x, Gaultheria procumbens 20x, Hepar sulph. calc. 20x, Iodium 20x, Lachesis 20x, Nux vom. 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Veratrum viride 20x, Verbascum 20x, Apis mel. 8x, Echinacea 8x, Apis mel. 3x, Echinacea 3x.

Purpose Section

Formulated for symptoms associated with abscesses, ulcerations, cellulitis, sepsis, fever and other inflammatory and infectious processes.

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 or 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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