Cough Medicine for Children Under 2 Years Old
Over-the-counter cough and cold medicines should NOT be used in children under 2 years of age due to lack of efficacy and risk of significant morbidity and mortality. 1, 2
What NOT to Use
Absolutely Contraindicated Medications
- All OTC cough and cold medicines are contraindicated in children under 2 years, as they provide no benefit and carry serious safety risks including death 1, 2, 3
- Codeine-containing medications must be avoided due to potential respiratory distress and serious adverse effects 2
- Antihistamines have minimal to no efficacy for cough relief and are associated with adverse events, with 69 reported fatalities in children under 6 years between 1969-2006 1, 2, 3
- Dextromethorphan should not be used as it is no more effective than placebo and has been specifically advised against by the American Academy of Pediatrics 2
- Decongestants caused 54 fatalities in children under 6 years (43 deaths in infants under 1 year), demonstrating their narrow therapeutic window and cardiovascular/CNS toxicity risk 1, 3
Why These Medications Fail
The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended against OTC cough and cold medications for children under 6 years in 2007, and major manufacturers voluntarily removed products for children under 2 years from the market 1, 3. Controlled trials have consistently shown these combination products are ineffective for upper respiratory symptoms in young children 1, 3.
Recommended Approach
For Children 1-2 Years Old
- Honey is the only recommended treatment for acute cough in children over 1 year of age, providing more relief than diphenhydramine, placebo, or no treatment 2, 4
- Supportive care and watchful waiting are appropriate for most cases, as acute coughs are typically self-limiting viral infections 2, 4
For Infants Under 1 Year
- No medications should be used - only supportive care 2
- Never give honey to infants under 12 months due to risk of infant botulism 2
Environmental Interventions (All Ages)
- Eliminate tobacco smoke exposure and other environmental pollutants, which should be assessed in all children with cough 1, 2, 4
- Address parental expectations and specific concerns through education about the natural course of viral illness 1, 2
When to Re-evaluate
Acute Cough (< 4 weeks)
- Re-evaluate if the child is deteriorating or not improving after 48 hours 2
- Consider bacterial infection if high fever (≥38.5°C) persists for more than 3 days 2
Chronic Cough (> 4 weeks)
- All children with chronic cough require thorough clinical review using pediatric-specific protocols 2, 4
- Obtain chest radiograph and spirometry (if age-appropriate) 2, 4
- Look for specific "cough pointers" such as coughing with feeding, digital clubbing, or productive cough that suggest underlying disease 2, 4
Common Pitfalls to Avoid
- Prescribing OTC medications due to parental pressure despite lack of efficacy and safety concerns 2, 5
- Using adult cough management approaches in pediatric patients, as etiologic factors and treatments differ 1, 2
- Medication errors from incorrect dosing are common in young children and can lead to unintentional overdose 3
- Failure to re-evaluate children whose cough persists beyond expected timeframes 2, 4
- Empirical treatment for asthma or GERD without clinical features consistent with these conditions 2, 4
Special Considerations for Specific Conditions
- If asthma is suspected (with risk factors and chronic nonspecific cough), consider a 2-4 week trial of low-dose inhaled corticosteroids (400 μg/day beclomethasone or budesonide equivalent), but always re-evaluate after the trial period 1, 2, 4
- Beta-agonists like salbutamol should not be used in children with acute cough and no evidence of airflow obstruction 2
- GERD treatment should only be considered if gastrointestinal symptoms are present (recurrent regurgitation, dystonic neck posturing in infants, heartburn in older children), not for cough alone 2, 4