NDC 55714-4407 Bronchitis - Asthma

Influenza A Virus, Influenza B Virus, Antimon. Tart., Arsenicum Alb., Bryonia, Camphora, Chelidonium Majus, Cinchona, Drosera, Eucalyptus, Hepar Sulph. Calc., Histaminum Hydrochloricum, Ipecac., Kali Bic., Kali Carb., Kali Iod., Lycopodium, Myrrha, Natrum Sulphuricum, Nux Vom., Phosphorus, Pulsatilla, Sanguinaria, Spongia , Stannum Met., Tussilago Farfara, Verbascum, Echinacea, Lappa, Rumex Crisp.

NDC Product Code 55714-4407

NDC Code: 55714-4407

Proprietary Name: Bronchitis - Asthma 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: Influenza A Virus, Influenza B Virus, Antimon. Tart., Arsenicum Alb., Bryonia, Camphora, Chelidonium Majus, Cinchona, Drosera, Eucalyptus, Hepar Sulph. Calc., Histaminum Hydrochloricum, Ipecac., Kali Bic., Kali Carb., Kali Iod., Lycopodium, Myrrha, Natrum Sulphuricum, Nux Vom., Phosphorus, Pulsatilla, Sanguinaria, Spongia , Stannum Met., Tussilago Farfara, Verbascum, Echinacea, Lappa, Rumex Crisp. 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.
    • 55714-4407 - Bronchitis - Asthma

NDC 55714-4407-1

Package Description: 28.35 g in 1 BOTTLE, GLASS

NDC 55714-4407-2

Package Description: 56.7 g in 1 BOTTLE, GLASS

NDC Product Information

Bronchitis - Asthma with NDC 55714-4407 is a a human prescription drug product labeled by Newton Laboratories, Inc.. The generic name of Bronchitis - Asthma is influenza a virus, influenza b virus, antimon. tart., arsenicum alb., bryonia, camphora, chelidonium majus, cinchona, drosera, eucalyptus, hepar sulph. calc., histaminum hydrochloricum, ipecac., kali bic., kali carb., kali iod., lycopodium, myrrha, natrum sulphuricum, nux vom., phosphorus, pulsatilla, sanguinaria, spongia , stannum met., tussilago farfara, verbascum, echinacea, lappa, rumex crisp.. 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.

Bronchitis - Asthma 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.

  • INFLUENZA A VIRUS 30 [hp_X]/g
  • ANTIMONY POTASSIUM TARTRATE 15 [hp_X]/g
  • ARSENIC TRIOXIDE 15 [hp_X]/g
  • BRYONIA ALBA ROOT 15 [hp_X]/g
  • CAMPHOR (NATURAL) 15 [hp_X]/g
  • CHELIDONIUM MAJUS 15 [hp_X]/g
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/g
  • DROSERA ROTUNDIFOLIA 15 [hp_X]/g
  • EUCALYPTUS GLOBULUS LEAF 15 [hp_X]/g
  • CALCIUM SULFIDE 15 [hp_X]/g
  • HISTAMINE DIHYDROCHLORIDE 15 [hp_X]/g
  • IPECAC 15 [hp_X]/g
  • POTASSIUM DICHROMATE 15 [hp_X]/g
  • POTASSIUM CARBONATE 15 [hp_X]/g
  • POTASSIUM IODIDE 15 [hp_X]/g
  • LYCOPODIUM CLAVATUM SPORE 15 [hp_X]/g
  • MYRRH 15 [hp_X]/g
  • SODIUM SULFATE 15 [hp_X]/g
  • STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/g
  • PHOSPHORUS 15 [hp_X]/g
  • PULSATILLA VULGARIS 15 [hp_X]/g
  • SANGUINARIA CANADENSIS ROOT 15 [hp_X]/g
  • SPONGIA OFFICINALIS SKELETON, ROASTED 15 [hp_X]/g
  • TIN 15 [hp_X]/g
  • TUSSILAGO FARFARA 15 [hp_X]/g
  • VERBASCUM THAPSUS 15 [hp_X]/g
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/g
  • ARCTIUM LAPPA ROOT 3 [hp_X]/g
  • RUMEX CRISPUS ROOT 3 [hp_X]/g
  • INFLUENZA B VIRUS 30 [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.

Bronchitis - Asthma Product Label Images

Bronchitis - Asthma 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

Bronchitis-Asthma   Formulated for symptoms associated with bronchitis, pneumonia, asthma, croup and other respiratory system conditions.

Dosage & Administration Section

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

Active Ingredient Section

Active Ingredients: Influenzinum 30x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Camphora 15x, Chelidonium majus 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Ipecac. 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Lycopodium 15x, Myrrha 15x, Natrum sulphuricum 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Sanguinaria 15x, Spongia 15x, Stannum met. 15x, Tussilago farfara 15x, Verbascum 15x, Echinacea 3x, Lappa 3x, Rumex crisp. 3x.

Inactive Ingredient Section

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

Purpose Section

Formulated for symptoms associated with bronchitis, pneumonia, asthma, croup and other respiratory system conditions.

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 of 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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