FDA Label for Broncochem Maximum Cough Night

View Indications, Usage & Precautions

Broncochem Maximum Cough Night 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



The following side effects may occur, nausea, vomiting, dizziness, headache, or nervousness may occur, if any of these effects last or worsen, contact your doctor or pharmacist immediately.  Stop using this medicine and tell your doctor right away if you have dizziness, nervousness, or trouble sleeping. 


Otc-Purpose Section



Antitussive

Antihistamine


Otc - Active Ingredient Section



Dextromethorphan HBr

Mepyramine maleate


Uses



Temporarily relieves these symptoms in all formsof acute, subacute, and cronical cough of any origin, it is very effective in colds, rhinitis, pharyngitis, laryngitis, dry cough, smokers cough, ashma, nervous cough.


Do Not Use



Stop using this medicine and contact your doctor right away if any of these unlikely but serious side effects occur, fast and irregular heartbeat, mental mood changes such as confusion, hallucinations, nervousness, seizures, tremor, problems with to pee.

If you are taking any monoamine oxidase inhibitor (MAOI), or two weeks after stopping them (certain medications for depression or psycological conditions may contain them).  If you are not sure if your prescription contains an MAOI, coinsult a professional of health before taking this product.


Ask A Doctor/Pharmacist



Ask a doctor before use if yoy have

Liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to enlarged prostate gland, cough that occurs with too much phlegm (mucus), presistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.


Stop Use And Ask A Doctor If



Symptoms last more than 7 days, symptoms worsen or come back, you develop a headache that wont go away, fever, or skin rash.  If pregnant or breast-feeding ask a health professional before use.


Keep Out Of The Reach Of Children



In case of accidental overdose, seek professional help or go to poison control center immediately.


Dosage And Administration



Do not exceed 4 doses in a 24 hour period.

Adult and children 12 years and older: (5 or 10 mL) 3 times a day.

Children between 6 to 12 years old: (2.5 mL) 3 times a day.


Inactive Ingredient



Sugar, Sodium Benzoate, FD&C Yellow #5, Orange flavor, MEthyl  paraben, Propyl paraben, ethyl alcohol 95%, Sorbitol 70%, Purified water.


Package Label Principal Display Panel




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