The following Structured Product Label (SPL) was submitted to the FDA by Laboratorio Magancehm International Srl for the product Broncochem (NDC 65131-418). 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 warnings, active ingredients, uses, ask a doctor before use if your kid have, stop use and ask a doctor if, keep out of the reach of children, overdose warning, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Do not use
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or two weks after stopping the MAOI drug (certain drugs for depression, psuchiatric or emotional conditions may contain MAOI), if you are uncertain whether your prescription contains MAOI ask a doctor or pharmacist before taking this product
Dextromethorphan HBr.......10.00mg
Chlorpheniramine maleate...2.00mg
Temporarily relieves cold symptoms, cough, helps loosen phlegm (mucus) and dilute bronchial secretions to make coughs more productive.
Reduces allergic symptoms like runny nose and sneezing, irritated ans watery eyes, Itchy nose, Itchy throat, Allergy rhinitis
Cough with lots of phlegm
Chornic cough, asthma or emphysema
Respiratory problems
Chornic bronchitis
If your child is allergyc to another component of this formula
Symptoms last more than 5 days
If your child feels dizziness, nervous or cannot sleep
If the cough present fever and headache, this could be signs of a serious conditions
If new symptoms occur
Keep out of the reach of children
in case of accidental overdose, seek professional assistance or contact a poison control center immediately
Take only as directed, for your convenience a dosage spoon is provided
Do not exceed 4 doses in a 24-hour period
Children from 6 to 12 years-----10mL or cc every 6 hours
Children fron 2 to 6 years-------5mL or cc every 6 hours
Children under 2 years, ask your doctor
Store at 66-77*F (20-25*C), do not use if security cap is altered or broken
Propylene glycol, Gliceryn, Sorbitol 70%, Sucralose, Povidone, Sodium Chloride, Aloe vera, Methylparaben USP, Propylparaben USP, Ascorbic acid, Color Yellow #5, Dosodium Hedta, Orange flavor, Sodium hydroxide, Purified water
1-561-338-5221 or visit us at www.broncochem.com
Dextromethorphan HBr------Antitussive
Chlorpheniramine maleate--Antihistamine
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