FDA Label for Broncochem Cold And Flu Caplets

View Indications, Usage & Precautions

Broncochem Cold And Flu Caplets 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 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 motor vehicle or operating machinery.


Active Ingredients



Acetaminofen

Dextromethorphan HBr

Phenylephryne HCL

Chlorpheniramine Maleate


Purpose



Analgesic

Antihistaminic

Antitussive

Descongestant


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



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

Adults and children 12 years and over, take one tablet every 4 hours.

Do not exceed 6 doses in a 24 hour period


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


Inactive Ingredients



Cellulose Microcrystalline, Colloidal Silicon dioxide, Green Opadry, Magnesium Stearate, Pregelatinized Starch, PEG 4000


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