Broncochem Syrup
FDA Label NDC 65131-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Laboratorio Magnachem International Srl for the product Broncochem (NDC 65131-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding warning secction, active ingredients, purpose, keep out of the reach of children, indications and usage, dossage and administration, drug interactions section, inactive ingredient section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Active Ingredients

Guaifenesin

Dextromethorphan HBr

Purpose

Expectorant

Antitussive

Keep Out Of The Reach Of Children

In case of accidental overdose, seek professional assistance or contact a poison control center immediately

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.

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 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

Inactive Ingredient Section

Aloe Vera, Ammonium Glycyrrhizinate, Citric Acid, Disodium HEDTA, Glacial Acetic Acid, Strawberry flavor, Propylene Glycol, Purified Water, FD&C Red 40, Sodium Benzoate, Sodium Chloride, Sodium Saccharin, Sorbitol, Carboxymethylcellulose sodium, Total Sodium content: 12mg (in 10mL or cc)

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