At what age does the American Academy of Pediatrics (AAP) recommend administering over-the-counter (OTC) cough and cold medications to children without a prescription?

From the Guidelines

The American Academy of Pediatrics (AAP) recommends that parents should not administer over-the-counter cough and cold medications to children under 4 years old without a prescription, as stated in the most recent guideline from 2020 1. This guideline applies to common over-the-counter products containing ingredients such as dextromethorphan, guaifenesin, phenylephrine, and pseudoephedrine. For children under 4, the AAP suggests alternative methods for symptom relief, such as:

• Using saline nasal drops
• Honey for cough (in children over 1 year)
• Ensuring proper hydration These recommendations are based on concerns about the potential side effects of these medications in young children and their limited proven efficacy, as highlighted in the 2020 CHEST guidelines 1. Parents should always consult with a pediatrician before giving any medication to young children, especially those under 4 years old. The AAP's stance is rooted in the understanding that children's bodies process medications differently than adults, and their developing systems may be more susceptible to adverse effects, including reported death from toxicity in young children 1. Additionally, many common cold symptoms are self-limiting and will resolve on their own with supportive care, making the risks of medication use often outweigh the potential benefits in young children. It's also worth noting that the FDA has altered the labeling for prescription opioid cough and cold medicines to limit their use to adults ≥ 18 years, and other than honey, OTC cough medications have little, if any, benefit in the symptomatic control of acute cough in children, but are associated with adverse events 1.

From the Research

Age Recommendations for OTC Cough and Cold Medications

• The American Academy of Pediatrics (AAP) recommends that over-the-counter (OTC) cough and cold medications should not be administered to children under the age of 4 without a prescription 2, 3.
• According to the FDA advisory, OTC cough and cold products should not be used in children aged <2 years 3.
• A study found that 59% of pediatricians did not recommend OTC cough and cold products for children aged <2 years before the advisory, and 35% were less likely to do so afterward 3.
• Another study reported that 53% of parents with children aged <2 years and 10% of parents with children aged 2 to 11 years did not use these products before the advisory, and an additional 33% and 28%, respectively, were less likely to do so afterward 3.

Safety Concerns and Medication Errors

• Serious adverse effects have been reported from cough/cold product use in infants and children, which largely result from inappropriate use by caregivers 2.
• Medication errors from OTC cough and cold medications can have significant public health impact, with nearly half of errors involving children 2 to <6 years old 4.
• Diphenhydramine and dextromethorphan were responsible for most medication errors and medication errors involving health care facility evaluation 4.
• Parental misinterpretations of OTC pediatric cough and cold medication labels are common, with factors such as label language and graphics influencing inappropriate interpretation 5.