Use extreme caution when giving cough- or cold medicine to children under 2

My father in-law, a well-respected family doctor and extremely conscientious grandparent, passed along this article based on a Medwatch alert from the FDA. According to the alert, the risk of overdosing infants and toddlers with over-the-counter cold and/or cough medicine is real and dangerous. Tragically, the three infants cited in the alert died due to overdose.

The US Food and Drug Administration (FDA) has warned healthcare professionals regarding the need for caution when administering cough and cold medications to infants younger than 2 years. Clinicians should also ask caregivers about their use of over-the-counter (OTC) combination medications to avoid the risk for overdose from component duplication…

…The CDC notes that although OTC sales of pseudoephedrine-containing products have been banned, some pediatric cough and cold medications containing the drug may still be sold behind the counter.

As an alternative to cough and cold medication in infants, use of a rubber suction bulb to clear congestion should be considered; secretions can be softened with saline nose drops or a cool-mist humidifier.

According to the CDC, systematic reviews of controlled trials of OTC cough and cold medications have concluded they are not more effective than placebo for reducing acute cough and other symptoms of upper respiratory tract infection in children younger than 2 years…

More: Best of Parent Hacks: Cold and flu season tips


  1. HDC says

    As an alternative, I’ve found that the pediacare vapor plug-ins help keep my little guy breathing more clearly at night when he’s stuffed up. Very highly recommended.

    And you should always, always, always be careful to stick to the dosing exactly as instructed for all painkillers like acetaminophen and ibuprofen as well.

  2. says

    We’ve had a lot of success with the cool humidifier and nasal aspirator.

    Our son, like most humans, disliked having an object shoved up his nose (may he retain this sensibility through his toddler years). We used sound effects to keep him from freaking out quite so much.

  3. says

    If you’re breastfeeding, you can use breastmilk instead of saline up the nose. It seems to bother the baby less (maybe because it tastes ‘normal’ when it eventually hits their throat, and doesn’t sting). It’s hard to squirt it directly “from the tap” so usually I gather some into a medicine syringe and use that as a dropper.

  4. says

    We use a vaporizer with liquid Vicks in it and that seems to help my daughter more than any cough or cold medicine. We turn it on 30-60 minutes before she goes to bed and close the door to her room so it gets good and steamy before she lies down. We also put a pillow between the mattress and box springs (or under the crib mattress before she move to a bed) to elevate her head.

  5. says

    You had me at “placebo”. That means no one should be taking these medicines!

    We like humidifiers and Vicks too. I’ve heard you need to watch a young child closely if they are very congested and you use something like Vicks Vaporub because it can actually be so effective they can, um, choke. Probably most crucial with infants, but something to keep in mind. We have also resorted to “Little Noses” squirt-up stuff that helps with upper-respiratory congestion. Not popular with kiddos, but it works.