Broncochem Maximum Cough

Dextromethorphan Hbr-gyaifenesin

Laboratorio Magnachem International Srl
Human Otc Drug
NDC 65131-091

Broncochem Maximum Cough also known as Dextromethorphan Hbr-gyaifenesin is a human otc drug labeled by 'Laboratorio Magnachem International Srl'. National Drug Code (NDC) number for Broncochem Maximum Cough is 65131-091. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Broncochem Maximum Cough drug includes Dextromethorphan Hydrobromide - 30 mg/10mL Guaifenesin - 200 mg/10mL . The currest status of Broncochem Maximum Cough drug is Active.

Drug Information:

Drug NDC:	65131-091
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:	Broncochem Maximum Cough
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Broncochem
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	MAXIMUM COUGH
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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:	Dextromethorphan Hbr-gyaifenesin
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Laboratorio Magnachem International Srl
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Syrup
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:	DEXTROMETHORPHAN HYDROBROMIDE - 30 mg/10mL GUAIFENESIN - 200 mg/10mL
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:	OTC MONOGRAPH FINAL
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:	30 Dec, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	25 Dec, 2025
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.
Application Number:	part341
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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:	LABORATORIO MAGNACHEM INTERNATIONAL SRL
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1234473
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UPC:	0805418091080
UPC stands for Universal Product Code.
NUI:	N0000193956 N0000008867 N0000009560
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	9D2RTI9KYH 495W7451VQ
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:	Expectorant [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:	Decreased Respiratory Secretion Viscosity [PE] Increased Respiratory Secretions [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:	Sigma-1 Agonist [EPC] Sigma-1 Receptor Agonists [MoA] Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] Uncompetitive NMDA Receptor Antagonists [MoA]
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
65131-091-08	1 BOTTLE, PLASTIC in 1 BOX (65131-091-08) / 120 mL in 1 BOTTLE, PLASTIC	30 Dec, 2016	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

Broncochem Maximum Cough

Dextromethorphan Hbr-gyaifenesin

Syrup
LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC: 65131-091

Purpose:

Purpose expectorant antitussive

Product Elements:

Broncochem maximum cough dextromethorphan hbr-gyaifenesin dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin anhydrous citric acid sodium benzoate carboxymethylcellulose sodium sodium chloride fd&c red no. 40 disodium hedta ammonium glycyrrhizate saccharin sodium acetic acid propylene glycol raspberry sorbitol aloe vera leaf water

Drug Interactions:

Drug interactions section do not use if you are now taking a prescription monoamine oxidase inhibitor (maoi), (certain drugs for depression, psychiatric or emotional conditions or parkinsons disease), or 2 weeks after stopping the maoi drug. id you are uncertain ehether your prescription drug contains an maoi, consult a health professional before taking this product

Indications and Usage:

Indications and usage temporarily relieves cough due to minor throat and bronchial irritation occuring with common cold. helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive. this new formulation with aloe results a natural cleanser, penetrates tissue, bactericidal, viruscidal, and fungicidal, enhances normal cell proliferation and moisturizes tissues (this statements are not yet evaluated by the food and drugs administration "fda") broncochem maximum cough has not drowsiness effect. work in chest congestion, its specially formulated for children and adults.

Warnings:

Warning secction do not take this product for persitent or chronic cough such as occurs with smoking, asthma, or emphysema or if cough is accompainied with excessive phlegm (mucus) unless directed by a doctor. persistent cough may be the sign of a serious condition. stop use and dask a doctor if symptoms persist or last more than 5 days (children) or 7 days (adults), tends to recur, is accompained or followed by fever, headache, rash, swelling, nausea or vomiting, consult a doctor. do not take this product if you are hypersensitive to any of the ingredients. as with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. avoid alcoholic beverages while taking this product.

Dosage and Administration:

Dossage and administration do not exceed 6 doses in a 24 hour period adults and children 12 years and over: (10ml or cc) every 4 hours children 6 years up to 12 years: (5ml or cc) every 4 hours

Drug Interactions:

Package Label Principal Display Panel:

Package label principal display panel image descriptionbmcusabox

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.