At what age can children safely take over-the-counter (OTC) cold medications?

Safe Age for Over-the-Counter Cold Medications in Children

Children under 4 years of age should not use over-the-counter (OTC) cold medications, and these medications should generally be avoided in all children under 6 years of age due to potential toxicity and lack of proven efficacy. 1

Age-Based Recommendations

• Children under 4 years: OTC cold medications should not be used at all due to FDA warnings and manufacturer relabeling following reports of serious adverse events including deaths 1

• 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 1

• Children 6 years and older: May use OTC cold medications according to package directions, but benefits remain limited 1

Safety Concerns

• Between 1969 and 2006, there were 54 fatalities associated with decongestants (pseudoephedrine, phenylephrine, and ephedrine) and 69 fatalities associated with antihistamines (diphenhydramine, brompheniramine, and chlorpheniramine) in children under 6 years 1

• Common causes of adverse events include:

  • Use of multiple cold/cough products containing the same ingredients 1
  • Medication dosing errors 2
  • Accidental exposures 2
  • Intentional overdose 1

• In 2007, major manufacturers voluntarily removed cough and cold medications for children under 2 years from the OTC market 1

• In 2018, the FDA altered labeling for prescription opioid cough and cold medicines to limit their use to adults ≥18 years 1

Efficacy Considerations

• Controlled trials have shown that antihistamine-decongestant combination products are not effective for symptoms of upper respiratory tract infections in young children 1, 3

• OTC cough medications have little, if any, benefit in the symptomatic control of acute cough in children 1, 4

• The common cold is generally a mild, self-limited illness that usually improves with time regardless of treatment 5

Alternative Approaches

• For children with acute cough, honey may offer more relief for cough symptoms than no treatment, diphenhydramine, or placebo (only for children 1 year and older due to botulism risk) 1, 4

• Safe and effective treatments for children include:

  • Acetaminophen for fever and pain (follow age-appropriate dosing) 6, 4
  • Nasal saline irrigation 4
  • Topical application of ointment containing camphor, menthol, and eucalyptus oils (for older children) 4

Prevention

• Hand hygiene is the best way to prevent transmission of cold viruses 4

• Prophylactic probiotics, zinc sulfate, and nasal saline irrigation may reduce the incidence of colds in children 3

Remember that the primary goal is to ensure child safety while managing symptoms. When in doubt about treating cold symptoms in young children, consult with a healthcare provider rather than using OTC cold medications.