Study: Misleading labels on over-the-counter children’s medications could lead parents to overdose their kids.

Take a close look to make sure your kids get medicine that's appropriate for their age.

RODALE NEWS, EMMAUS, PA—Young children are at an increased risk for overdose of drugs commonly found in over-the-counter cold and cough medications, such as antihistamines and decongestants. That’s why the U.S. Food and Drug Administration recommends against their use in children under age 2. Still, many parents may be misled by the labeling of these products, according to research published in the June issue of the journal Pediatrics. In the study, 86 percent of parents who examined the front label of an over-the-counter cold and cough medication thought it was okay to use in children younger than 2 years old, and more than half of participants thought it was all right to give the medication to a 13-month-old child with cold symptoms.

THE DETAILS: Researchers recruited 182 caregivers (87 percent were mothers) from three pediatric clinics between September 2006 and October 2007, and asked them to look at the front of a package of children’s cold and cough medicine. The researchers found that 86 percent of the time, parents thought the medicine was OK for a child under 2, even though the product label stated to consult a physician before giving it to a child of that age. Caregivers were then asked how they had reached that decision. Many reported being influenced by images such as babies, teddy bears, and droppers, words such as “infant” on the package, and statements such as “Pediatrician Recommended.” While participants with lower math skills were more likely to think a medication was fine for a child under 2, the opposite was also true, with parents having the highest number skills also being more likely to deem it safe (perhaps because they were more confident in their abilities to interpret the directions found on the back of the label).

WHAT IT MEANS: Although the medications used in this study were voluntarily removed from drugstore shelves in 2007 (just as recruitment for the study was ending), the researchers believe their data still illustrates how commonly OTC medication packaging is misinterpreted by parents. “The point of the study was to prove there is a disconnect between the front and the back of many of these boxes, and to point out the need for a change in labeling,” says Nicole Lokker, PharmD, a pediatric pharmacist at American Family Children’s Hospital and coauthor of the study. Lokker and her colleagues agree that drug companies should lower the literacy level of their labeling so fewer people are confused. She also points out that though companies have already changed some of their labels, there are no laws in place to prevent misleading labels from appearing on shelves again in the future.

Until standards are established and packaging changes become mandatory, here is some advice for avoiding a dangerous medication mistake:

• Don’t give cold meds to infants. Never assume that an over-the-counter cold and cough medication intended for children is safe for infants: The FDA guidelines advise against using these drugs in children under age 2, and most manufacturers have voluntarily started labeling their products as inappropriate for children under 4. If your young child is suffering from a cold, there are plenty of natural remedies, including using bulb syringes to suction out mucus, running a humidifier to keep the air moist, and keeping the child’s head elevated to encourage proper drainage. Coordinate your treatment strategy with your pediatrician to make sure you’re not dealing with something more dangerous than a cold.

• Ignore the pictures. Don’t rely on graphics and pictures to indicate a medicine’s intended consumers. These images are intended to draw your attention and lure you in, but shouldn’t be relied upon for making healthcare choices. Always flip the box over and read the dosing instructions before buying any medicine, whether for kids or adults.