NDC 55714-2376 Cough - Airway

Influenza A Virus, Influenza B Virus, Antimon. Tart., Arsenicum Alb., Bryonia, Chelidonium Majus, Cinchona, Drosera, Eucalyptus, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Kali Carb.,kali Iod., Myrrha, Nat. Sulphuricum, Nux Vom., Phosphorus, Pulsatilla, Rumex Crisp., Sambucus Nig., Spongia, Tussilago Farfara, Verbascum, Echinacea, Lappa

NDC Product Code 55714-2376

NDC Code: 55714-2376

Proprietary Name: Cough - Airway 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, Chelidonium Majus, Cinchona, Drosera, Eucalyptus, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Kali Carb.,kali Iod., Myrrha, Nat. Sulphuricum, Nux Vom., Phosphorus, Pulsatilla, Rumex Crisp., Sambucus Nig., Spongia, Tussilago Farfara, Verbascum, Echinacea, Lappa 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.
    • 55714-2376 - Cough - Airway

NDC 55714-2376-0

Package Description: .5 mL in 1 BOTTLE, GLASS

NDC 55714-2376-1

Package Description: 30 mL in 1 BOTTLE, GLASS

NDC 55714-2376-2

Package Description: 59 mL in 1 BOTTLE, GLASS

NDC Product Information

Cough - Airway with NDC 55714-2376 is a a human over the counter drug product labeled by Newton Laboratories, Inc.. The generic name of Cough - Airway is influenza a virus, influenza b virus, antimon. tart., arsenicum alb., bryonia, chelidonium majus, cinchona, drosera, eucalyptus, histaminum hydrochloricum, hydrastis, kali bic., kali carb.,kali iod., myrrha, nat. sulphuricum, nux vom., phosphorus, pulsatilla, rumex crisp., sambucus nig., spongia, tussilago farfara, verbascum, echinacea, lappa. 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 Otc 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.

Cough - Airway 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]/mL
  • ANTIMONY POTASSIUM TARTRATE 15 [hp_X]/mL
  • ARSENIC TRIOXIDE 15 [hp_X]/mL
  • BRYONIA ALBA ROOT 15 [hp_X]/mL
  • CHELIDONIUM MAJUS 15 [hp_X]/mL
  • CINCHONA OFFICINALIS BARK 15 [hp_X]/mL
  • DROSERA ROTUNDIFOLIA FLOWERING TOP 15 [hp_X]/mL
  • EUCALYPTUS GLOBULUS LEAF 15 [hp_X]/mL
  • HISTAMINE DIHYDROCHLORIDE 15 [hp_X]/mL
  • GOLDENSEAL 15 [hp_X]/mL
  • POTASSIUM DICHROMATE 15 [hp_X]/mL
  • POTASSIUM CARBONATE 15 [hp_X]/mL
  • POTASSIUM IODIDE 15 [hp_X]/mL
  • MYRRH 15 [hp_X]/mL
  • SODIUM SULFATE 15 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 15 [hp_X]/mL
  • PHOSPHORUS 15 [hp_X]/mL
  • PULSATILLA VULGARIS 15 [hp_X]/mL
  • RUMEX CRISPUS ROOT 15 [hp_X]/mL
  • SAMBUCUS NIGRA FLOWERING TOP 15 [hp_X]/mL
  • SPONGIA OFFICINALIS SKELETON, ROASTED 15 [hp_X]/mL
  • TUSSILAGO FARFARA 15 [hp_X]/mL
  • VERBASCUM THAPSUS 15 [hp_X]/mL
  • ECHINACEA, UNSPECIFIED 3 [hp_X]/mL
  • ARCTIUM LAPPA ROOT 3 [hp_X]/mL
  • INFLUENZA B VIRUS 30 [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.

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: 04-17-2017 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.

Cough - Airway Product Label Images

Cough - Airway 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

Otc - Keep Out Of Reach Of Children Section

Keep out of reach of children

Otc - Pregnancy Or Breast Feeding Section

If
​pregnant or breast-feeding,​ ask a doctor before use.

Warnings Section

Warning:​Keep out of reach of children. Do not use ​if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If
​pregnant or breast-feeding, ​ask a doctor before use.

Inactive Ingredient Section

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

Questions Section

Www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Questions? 1.800.448.7256

Otc - Purpose Section

Formulated for symptoms such as wheezing, shortness of breath, congestion, coughing, dryness and painful breathing.

Otc - Active Ingredient Section

Equ al parts of Echinacea 3x, Lappa 3x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium majus 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig.15x, Spongia 15x, Tussilago farfara 15x, Verbascum 15x, Influenzinum 30x.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Indications & Usage Section

Cough - AirwayFormulated for symptoms such as wheezing, shortness of breath, congestion, coughing, dryness and painful breathing.

* Please review the disclaimer below.

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