OTC Medication Labels Can Be Confusing to Parents

< May 27, 2009 > -- A new study has found that medication labels on children's over-the-counter (OTC) cold medicine can be confusing to parents.

According to the study's lead researcher, Dr. Russell Rothman, an assistant professor of internal medicine and pediatrics at Vanderbilt University Medical Center in Nashville, Tenn, language that is easy to read with clearer graphics is necessary to guide the selection and safe use of the medications,

"The age indications of over-the-counter pediatric cold and cough products are difficult for caregivers to understand," Dr. Rothman says. "These misinterpretations may pose significant hazards to child safety."

In 2007, drug makers removed several OTC cold and cough medications from supermarkets and/or drugstores in cooperation with the US Food and Drug Administration (FDA) recommendation - do not  use OTC cough and cold medications in children younger than two years old. In regards to products that remained on store shelves, pharmaceutical companies changed the medication labels to reflect this recommendation as well.

Research Study and Conclusion

In this study, Dr. Rothman and his research team decided to evaluate how well parents understood information printed on medications labels of OTC cold medicines. The target population was parents with children four years old and greater. This population was selected because OTC products remained on the market specifically for this age group.

Researchers evaluated 182 parents as they read medication labels from four different OTC cold and cough medicines. These labels were taken from OTC products removed from the market earlier, because they had been labeled for "infant" use.

Each label advised consumers to contact a physician prior to using the medication in children who were two years old. According to study findings, about 86 percent of the time, parents thought that these OTC cough and cold medications could be given to children younger than two. In addition, dosing instructions were not read or clearly understood. 

Over 50 percent of the time, parents admitted giving these medications to children younger than two years old with cold symptoms, even though the label instructed them to consult a physician first. Parents stated that pictures of infants, teddy bears and droppers, and the word "infant" on labels influenced their decision.

Study findings also indicated that parents with poor math skills were more likely to give incorrect or inappropriate answers.

"Instructions on over-the-counter cough and cold medicines can be difficult to understand, and this can potentially lead to misuse and threats to child safety," Dr. Rothman says. "Labeling needs further improvements to aid parental understanding."

Some manufacturers may have recently changed labels on OTC medications, but "the changes made vary from product to product, and it is not uniform," Dr. Rothman adds.

"Manufacturers and the FDA should continue to work together to further improve current OTC labels," Dr. Rothman says. "This includes removing misleading graphics, using more uniform, plain language, improving the display of quantitative information and simplifying the Drug Facts Panel component of the label. Any warnings about use - related to age and other factors - need to be more prominently displayed using simple, uniform language with large, bold print that is easy to read and identify on the package."

Future Debates Regarding OTC Medication

Another concern besides labeling, according to Dr. Rothman, is whether the OTC products work and should be used in children.

Dr. Rothman feels there is limited data to support how well the medicines work in children younger than 6. "Parents should be cautious about using over-the-counter cold and cough medicines, particularly medicines that contain combinations of products," he says. "They should read packaging carefully and discuss with their doctor or other health-care providers before use."

Dr. Rothman feels that the research study highlighted important concerns about parental understanding of all OTC products and identified potential harms to children of all ages, not just those younger than two.

"We applaud the pharmaceutical industry's recent announcement to add warnings on these products for children less than four years old," Dr. Rothman says. "However, if over-the-counter cold and cough products marketed for children are to remain on the market, significant changes are necessary to make product packaging and labeling more clearly understandable by all caregivers. A single warning statement is unlikely to be sufficient."

Dr. Rothman adds that he hopes the study's findings "will be of use to the FDA as it continues to deliberate how better to inform the public about the appropriateness of over-the-counter medications."

Always consult your child's physician for more information.

Over-The-Counter Medicines for Infants and Children

Over-the-counter (OTC) drugs are medications you can buy for children without a doctor's prescription. They usually come as pills, capsules, or liquids, and are sold in drugstores or supermarkets.

OTC drugs have information on the bottle or box. Always read this information before using the medicine. This information tells you:

• how much to give
• how often to give it
• what the drug contains
• warnings about using the drug
• if the drug is safe for children of certain ages

Here are some tips from the American Academy of Pediatrics (AAP), the Pharmacist's Newsletter, and the US Food and Drug Administration (FDA) on how to give OTC medicines to children. It is important to know the child's weight, because recommended doses are based on age and weight.

Another recommendation is to always follow the directions for age and weight. If the recommended age is not the child's age, do not give the medicine.

If no dose is given on the bottle or package for children under 12 years old, ask your doctor or pharmacist if it is OK to give the medicine to the child, how much should you give, and when should you give it.

It is important to remember that liquid medicines usually come with a cup, spoon, or syringe to help measure the right dose. Always use these devices to give medicine to infants and very young children.

Using a kitchen teaspoon is not an accurate way to measure. A teaspoon is usually considered to be 5 cc or 5 mL, but teaspoons can vary in size from between 2 mL and 10 mL.

If a person mixes medicine in a bottle of milk or formula, first put the medicine in one ounce of milk and have the child drink it all. Then put the remaining amount of formula or milk in the bottle and let them finish however much more they want.

Always use a good light when measuring or giving medication. Insufficient light could cause you to give the wrong medicine or the wrong dose.

Please remember to never let young children take medicine by themselves.

Many OTC cough and cold medicines contain a combination of ingredients to treat several symptoms. A child might be getting some of the same ingredients in other medicines.

Be sure to read the list of active ingredients (the ingredients that make the medicine work) for each OTC medicine you give a child to make sure he or she is not getting the same medication in more than one. Always make sure that the total amount of a medicine does not exceed the recommended dose.

Combinations of medicines found in multi-symptom medicines may cause side effects in children. The AAP says, for example, that the combination of antihistamines and decongestants in some "cold remedy" medicines can have side effects such as hyperactivity, sleeplessness, and irritability in children.

To be safe, do not combine prescriptions, supplements, or multi-symptom medicines without checking with your health care provider or pharmacist.

Because of Reye syndrome, DO NOT give a child younger than 18 any product with aspirin or similar drugs called "salicylates" unless your doctor tells you to. Instead of aspirin or other salicylates, a child can be given acetaminophen (sold as Tylenol, Datril, and other brands).

Always consult your physician for more information.