At what age can Bromfed (Brompheniramine and Pseudoephedrine) be started?

Bromfed Age Restrictions for Pediatric Use

Bromfed (brompheniramine and pseudoephedrine combination) should not be used in children under 6 years of age due to documented fatalities, lack of proven efficacy, and significant safety concerns; for children 6 years and older, safer alternatives such as second-generation antihistamines or intranasal corticosteroids should be strongly preferred. 1, 2

Evidence-Based Age Restrictions

Children Under 6 Years: Contraindicated

• The FDA's Nonprescription Drugs and Pediatric Advisory Committees explicitly recommend against OTC cough and cold medications containing antihistamine-decongestant combinations in all children below 6 years of age. 1

• Between 1969 and 2006, there were 9 fatalities specifically associated with brompheniramine in children, with the majority occurring in children under 2 years of age. 1

• Controlled trials have definitively shown that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children. 1

• Drug overdose and toxicity were common events in pediatric cases, resulting from use of multiple cold/cough products, medication errors, accidental exposures, and intentional overdose. 1

Children 6 Years and Older: Use With Extreme Caution

• While technically available for children 6 years and older, Bromfed should be avoided in favor of safer, more effective alternatives. 2

• The pseudoephedrine component requires specific dosing: children ages 6 to 11 years should take 1 tablet every 4 to 6 hours, not exceeding 4 tablets in 24 hours. 3

• Pseudoephedrine exposure is common among US children, with concerning patterns including taking multiple pseudoephedrine-containing products concurrently and using for extended periods. 4

Safer Alternative Therapies (All Ages)

First-Line Recommendations

• Second-generation antihistamines (cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine) have demonstrated excellent safety profiles in young children and should be used instead of first-generation antihistamines like brompheniramine. 1, 2

• Cetirizine and loratadine are approved for children as young as 6 months of age, providing safe options for the youngest patients. 1, 5

• Intranasal corticosteroids are the most effective medication class for controlling allergic rhinitis symptoms and should be considered first-line treatment for children 3 years and older. 1, 2

• Fluticasone propionate is approved for children aged 4 years and older, while mometasone furoate is approved for those aged 3 years and older. 5

Critical Safety Concerns Specific to Bromfed Components

Brompheniramine (Antihistamine Component)

• First-generation antihistamines cause significant sedation and cognitive impairment that can affect school performance and driving ability in adolescents, even without subjective awareness of sedation. 1

• Anticholinergic effects include dry mouth, constipation, urinary retention, and increased risk for narrow-angle glaucoma. 1

• The sedative effects cannot be eliminated by administering only at bedtime due to prolonged plasma half-life and active metabolites. 1

Pseudoephedrine (Decongestant Component)

• Side effects include insomnia, loss of appetite, irritability, palpitations, and potential blood pressure elevation. 1

• Cardiovascular disease is an absolute contraindication for pseudoephedrine use in children. 2

• Hyperthyroidism is an absolute contraindication for pseudoephedrine use in children. 2

• Dangerous interactions can occur with stimulant medications used for ADHD management. 2

Common Clinical Pitfalls to Avoid

• Never assume OTC medications are safe for children simply because they are available without prescription—the evidence clearly demonstrates significant mortality risk in children under 6 years. 1, 2

• Avoid combination products entirely in young children—they increase overdose risk and provide no proven benefit over single-agent therapy. 1, 2

• Do not use first-generation antihistamines when second-generation agents are available—the safety profile is dramatically better with newer agents. 1, 2

• Monitor for concurrent use of multiple cough and cold products, as this was a common cause of overdose and fatalities in the surveillance data. 1, 4

• If blood pressure elevation occurs from pseudoephedrine, close monitoring is essential. 1, 2

Practical Dosing Guidance If Use Is Unavoidable (≥6 Years Only)

• Ensure the child is at least 6 years of age before any consideration of use. 1, 3

• Use only single-ingredient products when possible to minimize overdose risk. 6

• Verify no concurrent use of other cough/cold medications containing the same ingredients. 1, 4

• Limit duration of use to the shortest period necessary, avoiding extended use beyond a few days. 4

• Screen for absolute contraindications including cardiovascular disease, hyperthyroidism, and concurrent stimulant medication use. 2