Approved Cough Medications for Children Under 6 Years
No over-the-counter cough medications are approved or recommended for children under 6 years of age due to lack of proven efficacy and significant safety concerns, including documented fatalities. 1
Age-Specific Restrictions
Children Under 4 Years
- Absolutely avoid all OTC cough and cold medications - the American Academy of Pediatrics and FDA explicitly recommend against their use due to potential toxicity and lack of proven efficacy 1
- Between 1969-2006, there were 54 deaths associated with decongestants and 69 deaths associated with antihistamines in children under 6 years, with the majority occurring in the youngest children 1
Children 4-6 Years
- OTC cold medications should generally be avoided - the FDA's advisory committees recommended against their use in children under 6 years 1
- Controlled trials demonstrate that antihistamine-decongestant combinations are ineffective for upper respiratory tract infection symptoms in young children 1
Children 6 Years and Older
- May use OTC cold medications according to package directions, though benefits remain limited 1
What IS Recommended: Evidence-Based Alternatives
Honey (First-Line Treatment)
- The American Academy of Pediatrics recommends honey as the only approved treatment for acute cough in children over 1 year of age 2
- Honey provides more relief for cough symptoms than no treatment, diphenhydramine, or placebo 2
- Critical safety warning: Never give honey to infants under 12 months due to risk of infant botulism 2
Supportive Care
- Most acute coughs are self-limiting viral infections requiring only supportive care 2
- Environmental modifications including addressing tobacco smoke exposure 2
Medications That Must Be Avoided
Specific Agents to Never Use
- Dextromethorphan: The American Academy of Pediatrics specifically advises against its use for any type of cough in children, as it is no different than placebo 2
- Codeine-containing medications: Must be avoided due to potential serious side effects including respiratory distress and death; FDA restricted these to adults ≥18 years only 2
- Antihistamines: Have minimal to no efficacy for cough relief and are associated with adverse events 2
- Salbutamol/β2-agonists: No evidence supports their use in children with acute cough and no evidence of airflow obstruction 1
Why These Medications Are Dangerous
- OTC drugs are common causes of unintentional ingestion in children under 5 years 1
- Medication errors from incorrect dosing are common and can lead to unintentional overdose 1
- In 2007, major manufacturers voluntarily removed cough and cold medications for children under 2 years from the OTC market 1
When to Re-Evaluate
- Review the child if cough persists beyond 2-4 weeks for emergence of specific etiological pointers 2
- All children with chronic cough require thorough clinical review using pediatric-specific cough management protocols 2
- Chest radiograph and spirometry (if age-appropriate) should be obtained for children with chronic cough 2
Common Pitfalls to Avoid
- Do not prescribe OTC medications due to parental pressure despite lack of efficacy 2
- Do not use adult cough management approaches in pediatric patients 2
- Do not empirically treat for asthma, GERD, or upper airway cough syndrome without clinical features consistent with these conditions 2
- Assuming that cough always represents asthma and treating with bronchodilators without evidence of airflow obstruction 1