At What Age Can Cough Medication Be Used in Children?
Over-the-counter cough and cold medications should not be used in children under 4 years of age, and their use remains questionable even in children 4-6 years old due to lack of proven efficacy and documented fatalities. 1, 2, 3
Age-Specific Recommendations
Children Under 2 Years
- All OTC cough and cold medicines are contraindicated due to lack of efficacy and risk of significant morbidity and mortality 1, 2
- Between 1969-2006, there were 54 deaths from decongestants and 69 deaths from antihistamines in children under 6 years, with 43 decongestant deaths occurring in infants under 1 year 2, 3
- In 2007, major manufacturers voluntarily removed cough and cold medications for children under 2 years from the OTC market 3
- The FDA does not recommend use of products containing antihistamines or decongestants in this age group 4
Children 2-4 Years
- OTC cough medications should not be used - the American Academy of Pediatrics and FDA recommend against their use in children under 4 years 3
- Systematic reviews show these medications have little to no benefit in symptomatic control of acute cough 1, 3
Children 4-6 Years
- Generally should be avoided - the FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended against use in children under 6 years 3
- Controlled trials demonstrate antihistamine-decongestant combinations are ineffective for upper respiratory symptoms in young children 3
Children 6 Years and Older
- May use OTC cold medications according to package directions, though benefits remain limited 3
- Second-generation antihistamines (cetirizine, loratadine, fexofenadine) are preferable to first-generation agents due to better safety profiles 3
What TO Use Instead
Honey (First-Line Treatment)
- Recommended as the only treatment for acute cough in children over 1 year of age 1
- Provides more relief than no treatment, diphenhydramine, or placebo 1
- Never give to infants under 12 months due to botulism risk 1, 2
Supportive Care
- Nasal suctioning, humidification, and nasal saline are appropriate for infants and young children 5
- Most acute coughs are self-limiting viral infections requiring only supportive care 1
Specific Medications to AVOID
Codeine and Opioids
- Must be avoided in all children due to potential respiratory distress and death 1, 2
- In 2018, FDA restricted prescription opioid cough medicines to adults ≥18 years only 3
Dextromethorphan
- Should not be used in pediatric patients - no different than placebo in reducing nocturnal cough or sleep disturbance 1
- The American Academy of Pediatrics specifically advises against its use for any type of cough in children 1
Antihistamines
- Have minimal to no efficacy for cough relief and are associated with adverse events 1, 2
- 69 reported fatalities in children under 6 years between 1969-2006 2
Beta-Agonists (Salbutamol)
- Should not be used in children with acute cough and no evidence of airflow obstruction 3
- No evidence supports their use for non-specific cough 3
When to Re-Evaluate
- Re-evaluate if cough persists beyond 2-4 weeks for emergence of specific etiological pointers 1
- Chronic cough (>4 weeks) requires thorough clinical review using pediatric-specific cough management protocols 6, 1
- Chest radiograph and spirometry (if age-appropriate) should be obtained for children with chronic cough 6, 1
Red Flags Requiring Immediate Evaluation
- Coughing with feeding 6, 1
- Digital clubbing 6, 1
- Failure to thrive 1
- Wet/productive cough persisting beyond 4 weeks 6
Common Pitfalls to Avoid
- Using adult cough management approaches in pediatric patients 1
- Prescribing OTC medications due to parental pressure despite lack of efficacy 1
- Empirical treatment for asthma, GERD, or upper airway cough syndrome without clinical features consistent with these conditions 6, 1
- Medication errors from incorrect dosing, particularly in young children 3
- Using multiple cold/cough products containing the same ingredients 7