Cold-cough

Echinacea, Lappa, Antimon. Tart., Arsenicum Alb., Bryonia, Chelidonium Maj., Cinchona, Drosera, Eucalyptus, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Kali Carb., Kali Iod., Myrrha, Nat. Sulphuricum, Nux Vom., Phos., Pulsatilla, Rumex Crisp., Sambucus Nig., Spongia, Tussilago Far., Verbascum, Influenzinum.

Newton Laboratories, Inc.
Human Otc Drug
NDC 55714-4768

Cold-cough also known as Echinacea, Lappa, Antimon. Tart., Arsenicum Alb., Bryonia, Chelidonium Maj., Cinchona, Drosera, Eucalyptus, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Kali Carb., Kali Iod., Myrrha, Nat. Sulphuricum, Nux Vom., Phos., Pulsatilla, Rumex Crisp., Sambucus Nig., Spongia, Tussilago Far., Verbascum, Influenzinum. is a human otc drug labeled by 'Newton Laboratories, Inc.'. National Drug Code (NDC) number for Cold-cough is 55714-4768. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Cold-cough drug includes Anemone Pulsatilla - 15 [hp_X]/g Antimony Potassium Tartrate - 15 [hp_X]/g Arctium Lappa Root - 6 [hp_X]/g Arsenic Trioxide - 15 [hp_X]/g Bryonia Alba Root - 15 [hp_X]/g Chelidonium Majus - 15 [hp_X]/g Cinchona Officinalis Bark - 15 [hp_X]/g Drosera Anglica - 15 [hp_X]/g Echinacea, Unspecified - 6 [hp_X]/g Eucalyptus Gum - 15 [hp_X]/g and more. The currest status of Cold-cough drug is Active.

Drug Information:

Drug NDC:	55714-4768
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Cold-cough
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Echinacea, Lappa, Antimon. Tart., Arsenicum Alb., Bryonia, Chelidonium Maj., Cinchona, Drosera, Eucalyptus, Histaminum Hydrochloricum, Hydrastis, Kali Bic., Kali Carb., Kali Iod., Myrrha, Nat. Sulphuricum, Nux Vom., Phos., Pulsatilla, Rumex Crisp., Sambucus Nig., Spongia, Tussilago Far., Verbascum, Influenzinum.
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Newton Laboratories, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Pellet
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	ANEMONE PULSATILLA - 15 [hp_X]/g ANTIMONY POTASSIUM TARTRATE - 15 [hp_X]/g ARCTIUM LAPPA ROOT - 6 [hp_X]/g ARSENIC TRIOXIDE - 15 [hp_X]/g BRYONIA ALBA ROOT - 15 [hp_X]/g CHELIDONIUM MAJUS - 15 [hp_X]/g CINCHONA OFFICINALIS BARK - 15 [hp_X]/g DROSERA ANGLICA - 15 [hp_X]/g ECHINACEA, UNSPECIFIED - 6 [hp_X]/g EUCALYPTUS GUM - 15 [hp_X]/g Load more... GOLDENSEAL - 15 [hp_X]/g HISTAMINE DIHYDROCHLORIDE - 15 [hp_X]/g INFLUENZA A VIRUS - 30 [hp_X]/g INFLUENZA B VIRUS - 30 [hp_X]/g MYRRH - 15 [hp_X]/g PHOSPHORUS - 15 [hp_X]/g POTASSIUM CARBONATE - 15 [hp_X]/g POTASSIUM DICHROMATE - 15 [hp_X]/g POTASSIUM IODIDE - 15 [hp_X]/g RUMEX CRISPUS ROOT - 15 [hp_X]/g SAMBUCUS NIGRA FLOWERING TOP - 15 [hp_X]/g SODIUM SULFATE - 15 [hp_X]/g SPONGIA OFFICINALIS SKELETON, ROASTED - 15 [hp_X]/g STRYCHNOS NUX-VOMICA SEED - 15 [hp_X]/g TUSSILAGO FARFARA - 15 [hp_X]/g VERBASCUM THAPSUS - 15 [hp_X]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date:	02 Sep, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	05 May, 2026
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Newton Laboratories, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
NUI:	N0000185375 N0000175629 N0000184306 N0000185001 M0000728 M0016962 M0516536
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	I76KB35JEV DL6OZ476V3 597E9BI3Z3 S7V92P67HO T7J046YI2B 7E889U5RNN S003A158SB J61BY05EGY 4N9P6CC1DX 72T9EZC2VX Load more... ZW3Z11D0JV 3POA0Q644U R9HH0NDE2E 1314JZ2X6W JC71GJ1F3L 27YLU75U4W BQN1B9B9HA T4423S18FM 1C4QK22F9J 9N1RM2S62C CT03BSA18U 0YPR65R21J 1PIP394IID 269XH13919 0JXZ63016V C9TD27U172
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:	Non-Standardized Plant Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:	Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:	Allergens [CS] Plant Proteins [CS] Seed Storage Proteins [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:	Allergens [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
55714-4768-1	28 g in 1 BOTTLE, GLASS (55714-4768-1)	02 Sep, 2019	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Other medicines with the same generic name

Cold-cough

Echinacea & more..

Pellet
Newton Laboratories, Inc.
NDC: 55714-4768

Purpose:

Otc - purpose section formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Product Elements:

Cold-cough echinacea, lappa, antimon. tart., arsenicum alb., bryonia, chelidonium maj., cinchona, drosera, eucalyptus, histaminum hydrochloricum, hydrastis, kali bic., kali carb., kali iod., myrrha, nat. sulphuricum, nux vom., phos., pulsatilla, rumex crisp., sambucus nig., spongia, tussilago far., verbascum, influenzinum. sucrose influenza a virus influenza a virus antimony potassium tartrate antimony cation (3+) arsenic trioxide arsenic cation (3+) bryonia alba root bryonia alba root chelidonium majus chelidonium majus cinchona officinalis bark cinchona officinalis bark drosera anglica drosera anglica eucalyptus gum eucalyptus gum histamine dihydrochloride histamine goldenseal goldenseal potassium dichromate dichromate ion potassium carbonate carbonate ion potassium iodide iodide ion myrrh myrrh sodium sulfate sodium sulfate anhydrous strychnos nux-vomica seed strychnos nux-vomica seed phosphorus phosphorus anemone pulsatilla anemone pulsatilla rumex crispus root rumex crispus root sambucus nigra flowering top sambucus nigra flowering top spongia officinalis skeleton, roasted spongia officinalis skeleton, roasted tussilago farfara tussilago farfara verbascum thapsus verbascum thapsus echinacea, unspecified echinacea, unspecified arctium lappa root arctium lappa root influenza b virus influenza b virus

Indications and Usage:

Indications & usage section formulated for coughs associated with allergies, post-nasal drip, croup and colds.

Warnings:

Warnings section warnings: 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.

Dosage and Administration:

Dosage & administration section directions : ages 12 and up, take 6 drops or pellets by mouth (ages 4 to 11, give 3 drops or pellets) one to four times daily or as directed by a health professional. under age 4, consult a health professional. under age 2, crush/dissolve pellets in purified water.

Package Label Principal Display Panel:

Package label package label

Further Questions:

Questions section newtonlabs.net - questions? 800.448.7256 newton laboratories, inc. fda est # 1051203 conyers, ga 30013

Comments/ Reviews:

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