Broncochem Expectorant Ii

Acetaminophen-chlorpheniramine Maleate-dextromethorphan Hbr-guaifenesin-phenylephrine Hcl

Laboratorio Magnachem International Srl
Human Otc Drug
NDC 65131-116

Broncochem Expectorant Ii also known as Acetaminophen-chlorpheniramine Maleate-dextromethorphan Hbr-guaifenesin-phenylephrine Hcl is a human otc drug labeled by 'Laboratorio Magnachem International Srl'. National Drug Code (NDC) number for Broncochem Expectorant Ii is 65131-116. This drug is available in dosage form of Syrup. The names of the active, medicinal ingredients in Broncochem Expectorant Ii drug includes Acetaminophen - 250 mg/10mL Chlorpheniramine Maleate - 4 mg/10mL Dextromethorphan Hydrobromide - 13.33 mg/10mL Guaifenesin - 200 mg/10mL Phenylephrine Hydrochloride - 5 mg/10mL . The currest status of Broncochem Expectorant Ii drug is Active.

Drug Information:

Drug NDC:	65131-116
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 Expectorant Ii
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:	EXPECTORANT II
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:	Acetaminophen-chlorpheniramine Maleate-dextromethorphan Hbr-guaifenesin-phenylephrine Hcl
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:	ACETAMINOPHEN - 250 mg/10mL CHLORPHENIRAMINE MALEATE - 4 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE - 13.33 mg/10mL GUAIFENESIN - 200 mg/10mL PHENYLEPHRINE HYDROCHLORIDE - 5 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 NOT 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 Jun, 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.
Application Number:	part343
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:	1743369
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:	0805418116875
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:	362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
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:	Adrenergic alpha1-Agonists [MoA] Histamine H1 Receptor Antagonists [MoA] Histamine-1 Receptor Antagonist [EPC] Sigma-1 Agonist [EPC] Sigma-1 Receptor Agonists [MoA] Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC] Uncompetitive NMDA Receptor Antagonists [MoA] alpha-1 Adrenergic Agonist [EPC]
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
65131-116-87	1 BOTTLE, PLASTIC in 1 BOX (65131-116-87) / 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 Expectorant Ii

Acetaminophen-chlorpheniramine Maleate-dextromethorphan Hbr-guaifenesin-phenylephrine Hcl & more..

Syrup
LABORATORIO MAGNACHEM INTERNATIONAL SRL
NDC: 65131-116

Purpose:

Purpose analgesic antihistaminic antotussive expectorant decongestant

Product Elements:

Broncochem expectorant ii acetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine saccharin sodium sodium benzoate sodium chloride ammonium glycyrrhizate disodium hedta citric acid monohydrate sorbitol propylene glycol acetic acid raspberry fd&c red no. 40 water

Drug Interactions:

Drug interaction precautions do not use if you are now taking a prescription monoamine oxidase inhibitor (maoi). (certain drugs for depression, psychiatric or emotional conditions, or parkinson`s disease), or 2 weeks after stopping the maoi drug. if you are uncertain whether your presciption drug contains an maoi, consult a health professional before taking this product

Indications and Usage:

Indications & use bronchial congestion irritation of the respiratory passages nasal congestion helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive antitussive temporarilly relieves allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergic rhinitis

Warnings:

Warnings unless directed by a physician do not take this product if persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or if cough is accompanied by excessive phlem (mucus). likewise if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, if nervousness, dizziness, or sleeplesness occur, discontinue use or consult a doctor, if symptoms do not improve within 7 days or are accompainied by fever, consult a doctor. a persistent cough may be a sing of a serious condition. stop use and ask a doctor if symptoms persist or last long that 5 days (children) or 7 days (adults), tend to return, arash, or persistent headache. as with any drug, if you are pregnant or nursing a baby; seek the advice of a healh professional before using this product. unless directed by a doctor, do not take this product if you are presently taking another product containing pseudoephedri Read more...

ne hcl, or if you are taking sedatives or trankilizers; it may increase the drowsiness effect. avoid alcoholic beverages while taking this product. use caution when driving a motor vehicle or operating machinery.

Dosage and Administration:

Dosage and administration do not exceed 4 doses in a 24 hour period adults and chuildren 12 years and over: (10ml or cc) using metered dosage spoon every 6 hours. children 6 years up to 12 years: (5ml or cc) using metered dosage spoon every 6 hours

Drug Interactions:

Package Label Principal Display Panel:

Package label principal display panel busaiibox

Iactive ingredient aloe vera, ammonium glycyrrhizinate, citric acid, disodium edta, glacial acetic acid, natural raspberry flavor, propylene glycol usp, purified water, fd&c red no.40, sodium benzoate, sodium saccharin usp, sorbitol 70%.

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.