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:
- Cough suppressants (dextromethorphan or DM)
- Cough expectorants (guaifenesin)
- Decongestants (pseudoephedrine and phenylephrine)
- Certain antihistamines (such as brompheniramine, chlorpheniramine maleate, and diphenhydramine [Benadryl])
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.
Should my child use kids' cold medicine?
The current recommendations from the FDA are:
- Do not use cold and cough medicines in children under age 4 unless advised by your doctor.
- Never give adult medicines to children. Only use medicines designed for children.
- Never use a cold or cough drug if your child takes other prescription or over-the-counter medicines, unless you’ve checked with the doctor first.
- Carefully follow the instructions for dosing on the box.
- Use the enclosed measuring spoon, dropper, or dosing cup.
- Take your child to the doctor if symptoms worsen or don’t improve within a few days.
Also, many experts say that parents should go further and stop using any kids’ cold medicine in children under age 6 unless their doctors recommend it.
In 2014, the American Academy of Pediatrics called on the FDA to make such a recommendation. In addition, the AAP asked that OTC cold/cough medicine manufacturers to use weight-based rather than age-based dosing recommendations, saying weight is more accurate for determining the correct dose of a drug. The AAP also asked that dosing devices have a flow-limiting capacity to prevent against overdose.
What can I give my kids for a cold or cough?
Nothing cures a cold, but pediatricians say these strategies may help:
- Call the child's doctor right away if he is three months of age or younger at the first sign of an illness.
- Reduce the child's fever using appropriate medication (check with a doctor), such as acetaminophen (Tylenol). Do not use ibuprofen in children under age 6 months or if your child is vomiting or dehydrated. Do not use aspirinwith any child because of the risk of Reye's syndrome, a rare but serious disease.
- Consider using honey for coughs or sore throat for kids, but only if they are older than age 1.
- Try saline drops or spray to clear thick mucus out of your child's nose.
- Give your child plenty of liquids to increase hydration and help thin mucus.
- Use a humidifier in your child's room to add moisture to the dry air.
- If your child wheezes, call your doctor. Other treatments may be needed to help open airways.
- To ease congestion, keep the child's head elevated when resting.