What is the best practice for using over-the-counter (OTC) cough medicine in children under 10 years old?

Best Practice for OTC Cough Medicine in Children Under 10 Years

Over-the-counter cough medicines should NOT be used in children under 10 years old, as they have not been shown to reduce cough severity or duration, and are associated with significant morbidity and even mortality. 1

Age-Specific Recommendations

Children Under 4 Years

• Absolutely avoid all OTC cough and cold medications due to potential toxicity and complete lack of proven efficacy 2
• Between 1969-2006, there were 54 deaths associated with decongestants and 69 deaths associated with antihistamines in children under 6 years, with 43 decongestant deaths occurring in infants under 1 year 2
• The FDA and American Academy of Pediatrics explicitly recommend against use in this age group 2
• Major manufacturers voluntarily removed cough and cold medications for children under 2 years from the OTC market in 2007 2

Children 4-6 Years

• OTC cold medications should generally be avoided, as the FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended against their use in children under 6 years 2
• Controlled trials demonstrate that antihistamine-decongestant combinations are ineffective for upper respiratory tract infection symptoms in young children 2

Children 6-10 Years

• While FDA labeling permits use according to package directions in children 6 years and older, benefits remain extremely limited and these medications should still be avoided 2
• The evidence base for efficacy remains poor even in this older age group 1

Specific Medications to Avoid

Dextromethorphan

• Do not use in any pediatric patient - it is no different than placebo in reducing nocturnal cough or sleep disturbance 1
• The American Academy of Pediatrics specifically advises against dextromethorphan for any type of cough in children 1
• FDA labeling for dextromethorphan states "children under 4 years of age: do not use" 3

Codeine and Opioid-Based Medications

• Must be completely avoided due to potential serious side effects including respiratory distress and death 1
• The FDA restricted prescription opioid cough medicines to adults ≥18 years only in 2018 1, 2
• No evidence exists to support codeine or derivatives as antitussive agents for chronic cough in children 4

Antihistamines

• Have minimal to no efficacy for cough relief in children 1
• Associated with adverse events when combined with other OTC ingredients 1
• The American Academy of Pediatrics advises against antihistamines for cough relief in children 1

Guaifenesin (Expectorants)

• While FDA labeling permits use in children 2 years and older with physician consultation under age 2 5, systematic reviews show OTC cough medications have little to no benefit in symptomatic control of acute cough 2

Recommended Alternative: Honey

For children over 1 year old, honey is the ONLY recommended first-line treatment for cough 1

• Provides more relief for cough symptoms than no treatment, diphenhydramine, or placebo 1
• While not superior to dextromethorphan in head-to-head comparison, dextromethorphan should still be avoided due to lack of proven efficacy and potential adverse effects 1
• Never give honey to infants under 12 months of age due to risk of infant botulism 1

When to Seek Further Evaluation

Acute Cough (< 4 weeks)

• Most acute coughs are self-limiting viral infections requiring only supportive care 1
• Review the child if deteriorating or not improving after 48 hours 1
• Re-evaluate if cough persists beyond 2-4 weeks for emergence of specific etiological pointers 1

Chronic Cough (≥ 4 weeks)

• All children with chronic cough require thorough clinical review using pediatric-specific cough management protocols 1
• Obtain chest radiograph and spirometry (if age-appropriate) 1
• Look for specific cough pointers such as coughing with feeding, digital clubbing, or productive cough 1

Red Flags Requiring Immediate Evaluation

• Coughing with feeding 1
• Digital clubbing 1
• Failure to thrive 1
• High fever (≥38.5°C) persisting for more than 3 days 1

Common Pitfalls to Avoid

• Prescribing OTC medications due to parental pressure despite lack of efficacy - parents who desire medications at initial visit report more improvement at follow-up regardless of whether the child received medication, placebo, or no treatment 1
• Using adult cough management approaches in pediatric patients - etiologic factors and treatments differ significantly 1
• Medication errors from incorrect dosing are common, particularly in young children, and can lead to unintentional overdose 2
• Using multiple cold/cough products containing the same ingredients - a common cause of adverse events 2
• Failure to re-evaluate children whose cough persists despite treatment 1
• Empirical treatment for asthma, GERD, or upper airway cough syndrome without clinical features consistent with these conditions 1

Environmental Modifications

• Evaluate and address tobacco smoke exposure and other environmental pollutants in all children with cough 1
• Assess parental expectations and concerns as part of the clinical consultation 1
• Educational input addressing the child's specific condition is most successful 1