Making Sense of OTC Drug Use in Kids
It seems every time you on turn on the news or read a newspaper there is something new on how, when, or even if you can use over-the-counter (OTC) medications to treat your children’s sniffles, aches and pains, and fever.
What are concerned parents supposed to do, especially when their infant or toddler is up all night with a terrible cough or cold and flu season looms? WebMD spoke to Norman Tomaka and Elizabeth Shepard, MD, to find out. Tomaka is a certified consultant pharmacist in Melbourne, Fla., and a spokesperson for the American Pharmacists Association. Shepard is a clinical associate professor of pediatrics at Lucile Packard Children’s Hospital and Stanford University School of Medicine in Palo Alto, Calif.
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Here is what they had to say about parents’ most pressing questions regarding the safety of over-the-counter drugs when kids take them.
Is it ever safe to use OTC cough and cold products in children under 2?
The short answer is no, says Tomaka. In no uncertain terms, the FDA states that OTC cough and cold products such as decongestants, expectorants, antihistamines, and cough suppressants should not be used in children under 2 years old. These products are not safe and do not work in babies and toddlers. What’s more, they may be misused and can cause serious and potentially life-threatening side effects.
Is it safe to use over-the-counter drugs for kids older than 2?
Again, the short answer is no. OTC cold and flu medications should probably not be used in kids under age 4. But, Tomaka says, it’s not as black and white as it is in kids under 2. The FDA is reviewing research on how -- or if -- over-the-counter cold and flu products affect older children. Nevertheless, manufacturers of pediatric cough and cold drugs are voluntarily putting a warning on their products that states children under 4 should not take these products.
Are over-the-counter cough and cold medications OK for kids older than 5?
“Short-term use of OTC cold products is OK if there is a clear diagnosis,” Tomaka says. These products should not be used for more than three to five days.
“You can buy and give OTC cough and cold products to children aged 4 and over,” says Shepard. But talk to your doctor first, and never use more than one at a time.” She goes on to say, “Beware of combination products. There are many of them out there. Don’t give a cold medicine and Tylenol because the cold medicine may also have acetaminophen (the active ingredient in Tylenol) in it, and this can result in an overdose.”
The bottom line? “If the symptoms are mild, read the directions and use the product based on age and correct diagnosis,” Shepard says. “But if the symptoms are more severe, call a doctor and don’t give OTC medication. Call the doctor if your child has a high fever and is having breathing trouble such as chest pulling.”

