What are the recommendations for using cough syrup and antihistamines (anti-histamine) in children?

Cough Syrup and Antihistamine Use in Children

Direct Recommendation

Do not use over-the-counter cough syrups or antihistamines in children under 4 years of age due to lack of efficacy and significant safety concerns, including documented fatalities. For children 1 year and older with acute cough, use honey as first-line therapy instead. 1, 2

Age-Specific Guidelines

Children Under 4 Years

• Avoid all OTC cough and cold medications including antihistamines, decongestants, and antitussives due to potential toxicity and unproven benefit. 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. 3
• Controlled trials demonstrate that antihistamine-decongestant combinations are ineffective for upper respiratory tract infection symptoms in young children. 3
• Major manufacturers voluntarily removed cough and cold medications for children under 2 years from the market in 2007. 2

Children 4-6 Years

• Generally avoid OTC cold medications as the FDA's advisory committees recommended against use in children under 6 years. 2
• If treatment is deemed necessary after careful consideration, use only under physician guidance with precise dosing instructions. 4

Children 6 Years and Older

• May use OTC cold medications according to package directions, though benefits remain limited. 2
• For antihistamines like cetirizine, children 6 years and older can take one 10 mg tablet once daily. 5
• Second-generation antihistamines (cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine) are preferable to first-generation agents due to better safety profiles with minimal cognitive and antimuscarinic side effects. 3, 6

Recommended Alternative: Honey

For children over 1 year with acute cough, honey is the recommended first-line therapy. 1

• The American College of Chest Physicians recommends honey as superior to no treatment, placebo, or diphenhydramine. 1
• Honey is safer than codeine-containing medications, which should be avoided due to risk of respiratory distress. 1
• Never give honey to infants under 12 months due to risk of infant botulism. 1

Critical Safety Concerns

Common Causes of Adverse Events

• Use of multiple cold/cough products containing the same active ingredients leads to unintentional overdose. 2
• Medication errors from incorrect dosing are common, particularly in young children. 3
• Accidental exposures occur frequently as OTC drugs are common unintentional ingestions in children under 5 years. 2

Specific Drug Class Warnings

• Antihistamines: No evidence of effectiveness for acute cough in children; three studies showed they were no more effective than placebo. 7
• Antitussives: Variable results in adults, but no proven benefit in children under 6 years. 7
• Decongestants: Topical vasoconstrictors should be used with extreme care below age 1 year due to narrow therapeutic window and risk of cardiovascular and CNS side effects. 3

When to Seek Medical Evaluation

Re-evaluate if: 1

• Cough persists beyond 2-4 weeks
• Difficulty breathing or increased work of breathing develops
• Fever persists or appears later in illness
• Changes in mental status occur
• Child refuses to eat or drink

Common Pitfalls to Avoid

• Do not assume cough represents asthma and treat with bronchodilators without evidence of airflow obstruction. 2
• Do not prescribe multiple medications that may contain overlapping ingredients. 4
• Do not use medications off-label in children under 2 years where safety data are lacking. 8
• Do not recommend first-generation antihistamines when second-generation options are available for children 6 years and older. 6