Brompheniramine Maleate Safety and Efficacy in Young Children

Critical Safety Considerations

• The FDA and pediatric advisory committees have raised significant concerns about OTC cough and cold medications in young children, with 9 pediatric fatalities associated with brompheniramine between 1969-2006, primarily due to drug overdose and medication errors 1
• Efficacy of antihistamine-decongestant combinations has not been established for upper respiratory infections in children under 6 years, leading to recommendations against using OTC cough and cold medications in this age group 1
• Brompheniramine should only be used for clear allergic indications, such as allergic rhinitis or urticaria, rather than common cold symptoms in children under 6 years, as diagnosed by a healthcare professional 1