FDA Label for Broncochem Expectorant Ii

View Indications, Usage & Precautions

Broncochem Expectorant Ii Product Label

The following document was submitted to the FDA by the labeler of this product Laboratorio Magnachem International Srl. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 Pseudoephedrine 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.


Active Ingredients



Acetaminophen

Chlorpheniramine Maleate

Dextromethorphan HBr

Guaifenesin

Phenylephrine HCl


Purpose



Analgesic

Antihistaminic

Antotussive

Expectorant

Decongestant


Keep Out Of The Reach Of Children



In case of accidental overdose, seek professional assistancve or contact a poison control center inmediately


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


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 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


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%.

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%.


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