The following Structured Product Label (SPL) was submitted to the FDA by Laboratorio Magnachem International Srl for the product Broncochem (NDC 65131-098). 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, uses, active ingredients (in 10 ml or cc), ask a doctor or pharmacist if you, when using this product, stop use and ask a doctor if, keep out of the reach of children, overdose warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) or two weeks after stopping the MAOI drug (certain drugs for depression, psychiatric or emotional conditions may contain MAOI) If you are uncertain whether your prescription contains MAOI ask a doctor or oharmacist before taking this product.
Nasal congestion, irritation of the upper respiratory passages, temporarily reduces allergy, swelling of nasal passages, sneezing, itching of the nose or throat, itchy watery eyes, allergic rhinitis.
Chlorpheniramine Maleate.......4.00mg (antihistamine)
Phenylephrine HCl..................5.00mg (Decongestant)
Are taking sedatives or tranquilizers
Excitability may occur, especially in children.
May cause marked drowsiness
Avoid alcoholic drinks
Alcohol, sedatives and tranquilizers may increase drowsiness
Be careful when driving or operating machinery
Nervousness, dizziness or sleeplessness occur.
Symptoms last more than five days.
If fever is presented that last more than 3 days or headache appers, this could be signs of a serious condition.
Keep out of the reach of children.
If pregnant or breast-feeding, ask a doctor before taking this product.
In case of accidental overdose, seek professional assistance or contact a poison control center inmediately.
Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 4 doses in a 24-hour period.
Adults and Children from 12 years above 10mL or cc every 6 hours.
Children from 6 to 12 years 5mL or cc every 6 hours.
Children under 6 years, ask your doctor.
Store at 66-77
Propylene glycol, Glicerin, Sorbitol 70% USP, sucralose, Povidone, Sodium chloride, Aloe Vera, Metil paraben USP, Propil paraben USP, Propyl gallate, Citric acid, Sodium citrate dihydrate, EDTA disodium, Grape flavor, Purified water.
1-561-338-5221 or visit us at www.broncochem.com
Made in Dominican Republic by Laboratorio Magnachem International SRL to Global Corporation Inc. Boca Raton, Fl 33487
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