Broncochem Cold And Flu Caplets

Acetaminophen-dextromethorphan Hbr-phenylephrine Hcl-chlorpheniramine Maleate

Labotorio Magnachem International Srl
Human Otc Drug
NDC 65131-111

Broncochem Cold And Flu Caplets also known as Acetaminophen-dextromethorphan Hbr-phenylephrine Hcl-chlorpheniramine Maleate is a human otc drug labeled by 'Labotorio Magnachem International Srl'. National Drug Code (NDC) number for Broncochem Cold And Flu Caplets is 65131-111. This drug is available in dosage form of Tablet, Coated. The names of the active, medicinal ingredients in Broncochem Cold And Flu Caplets drug includes Acetaminophen - 325 mg/1 Chlorpheniramine Maleate - 3 mg/1 Dextromethorphan Hydrobromide - 30 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Broncochem Cold And Flu Caplets drug is Active.

Drug Information:

Drug NDC:	65131-111
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 Cold And Flu Caplets
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:	COLD AND FLU CAPLETS
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-dextromethorphan Hbr-phenylephrine Hcl-chlorpheniramine Maleate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Labotorio Magnachem International Srl
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Tablet, Coated
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 - 325 mg/1 CHLORPHENIRAMINE MALEATE - 3 mg/1 DEXTROMETHORPHAN HYDROBROMIDE - 30 mg/1 PHENYLEPHRINE HYDROCHLORIDE - 5 mg/1
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:	01 Jan, 2010
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	08 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.
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:	LABOTORIO MAGNACHEM INTERNATIONAL SRL
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1744049
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.
UNII:	362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 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:	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
65131-111-21	12 BOX in 1 BOX (65131-111-21) / 50 POUCH in 1 BOX (65131-111-95) / 2 TABLET, COATED in 1 POUCH	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 Cold And Flu Caplets

Acetaminophen-dextromethorphan Hbr-phenylephrine Hcl-chlorpheniramine Maleate

Tablet, Coated
LABOTORIO MAGNACHEM INTERNATIONAL SRL
NDC: 65131-111

Purpose:

Purpose analgesic antihistaminic antitussive descongestant

Product Elements:

Broncochem cold and flu caplets acetaminophen-dextromethorphan hbr-phenylephrine hcl-chlorpheniramine maleate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine chlorpheniramine maleate chlorpheniramine cellulose, microcrystalline starch, pregelatinized corn silicon dioxide magnesium stearate peg-80 stearate

Drug Interactions:

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

Indications and Usage:

Indications and usage bronchial congestion, irritation of the respiratory passages, nasal congestion. antitussive, temporary reliev of allergy symptoms including runny nose, sneezing, stuffy nose, itchy nose, itchy throat, irritated and watery eyes, allergy 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 accompained by excessive phlem (mucus). likewise if you have heart disease, diabetes, or difficulty in urination due to enlargement of the prostate gland, do not take this product unless directed by a physician. if nervousness, dizziness, or sleeplessness occurs, discontinue use or consult a doctor. if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor. a persistent cough may be a sign of a serius condition. if cough or other symptoms persist or not improve with any drug, if you are pregnant or nursing a baby, seeh the advice of a health professional before using this product. unless directed by a doctor, do not take this product if you are presently taking another product containing pseudoephedryne hcl, or if you are taking this product precaution must be taken when driving a Read more...

motor vehicle or operating machinery.

Dosage and Administration:

Indications and usage adults and children 12 years and over, take one tablet every 6 hours. do not exceed 4 doses in a 24 hour period

Drug Interactions:

Package Label Principal Display Panel:

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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.