Concerns about the safety and efficacy of over-the-counter cold medications have led to a recent U.S. Food and Drug Administration public health advisory against their use in children 2 years of age. This study's goal was to examine caregiver understanding of the age indication of over-the-counter cold medication labels and identify factors, associated with caregiver understanding. Caregivers of infant children (1 year old) were recruited from clinics at three institutions. Questions were administered regarding the use of four previously common “infant” over-the-counter cold and cough medicines labeled to consult a physician if used in children 2 years of age. Literacy and numeracy skills were assessed with validated instruments.
A total of 182 caregivers were recruited; 87 percent were the infants’ mothers. Mean education level was 12.5 years, and 99 percent had adequate literacy skills, but only 17 percent had 9th-grade numeracy skills. When examining the front of the product label, 86 percent of the time parents thought these products were appropriate for use in children 2 years of age. More than 50 percent of the time, parents stated they would give these over-the-counter products to a 13-month-old child with cold symptoms. Common factors that influenced parental decisions included label saying “infant,” graphics (e.g., infants, teddy bears, droppers), and dosing directions. Caregivers were influenced by the dosing directions only 47 percent of the time. Caregivers with lower numeracy skills were more likely to provide inappropriate reasons for giving an over-the-counter medication.
The authors conclude that misunderstanding of over-the-counter cold products is common and could result in harm if medications are given inappropriately. Label language and graphics seem to influence inappropriate interpretation of over-the-counter product age indications. Poorer parental numeracy skills may increase the misinterpretation of these products. Opportunities exist for the Food and Drug Administration and manufacturers to revise existing labels to improve parental comprehension and enhance child safety.