Kids' Cold Medicines: Guidelines
In 2008, the FDA strongly recommended against giving over-the-counter cough and cold medicines to children who are under age 2. However, rather than requiring manufacturers to warn consumers, the agency praised the voluntary actions of manufacturers to state on product labels not to give the medicines to children under age 4.
Evidence indicates that children's cold medicines don't really help and may pose a real (although small) risk of side effects, particularly to young children. This has cast serious doubt on a common and trusted group of medicines -- and left many parents anxious and confused.
Which kids' cold medicines are in question?
Specifically, four different categories of drugs. They are:
You might not recognize these drugs by name, but they are the active ingredients in many brands of kids' cold and cough medicines commonly available in drugstores.
What's the problem with kids' cold medicines?
One specific concern was that these medicines were often not studied in children. Instead, they were studied in adults, and those results were then applied to children. However, it's not clear that adults and children will react to these medicines in the same way. Even in adults, the evidence is weak that cough and cold medicines help.
What are the risks of using kids' cold medicines?
Experts agree that the risks from kids' cold and cough medicines are low, especially considering how common they are.
Still, thousands of children under age 12 go to emergency rooms each year after taking cough and cold medicines, according to the Centers for Disease Control. Roughly two-thirds of those ER visits occurred after children drank cough or cold medicine while unsupervised.
Taking too much cold medicine can produce dangerous side effects. Accidentally giving a child a dose that's too high can be easy to do; parents might use two different brands of medicine at the same time, not realizing they contain the same ingredients, or may incorrectly measure a dose if they get up in the middle of the night to soothe a child.
While the overall risks are low, some experts say that they are not low enough. Given that there's no evidence that kids' cold medicines help children, some consider any risk -- no matter how slight -- to be unacceptably high.