Self Care Pharmacy Blog


Are cold medicines safe in young children?

October 17th, 2013

By Maria Miller PharmD Student Cedarville University School of Pharmacy

Cold season is now upon us and that means doctor offices and pharmacies will be swarmed with people who are picking up prescriptions for their colds and buying over the counter medicine to help symptoms. Most people skip the doctor and head straight for over the counter medicines, including parents of young children.  Too often, parents are giving their children, 4 years and younger, cold medicine when they should not be. According to the Official Journal of the American Academy of Pediatrics, in the years 2004-2005, 5.7% of all emergency room visits were for children under the age of 12 who were experiencing adverse effects of cold medicine.1  Out of these children, 64% of them were between the ages of 2-5.1 Cold medicine products typically include pseudoephedrine, diphenhydramine, dextromethorphan, and guaifenesin.2  Labeling on these medicine bottles in 2008 stated it should not be used in children under 2 years of age. 3

An article posted in U.S. News during April 2013 discussed a survey that was given out to patients that asked if they administered cold medicines to their young children. The survey included 498 parents of children under the age of 3.3 The results showed that many parents gave their children cold medicines to help with their symptoms under the age of 4.3 According to the article, in 2008, labels on these over the counter cold medicines warned that they should not be given to children under 4.3 These medicines can cause allergic reactions, increased or uneven heart rate, slow and shallow breathing, confusion or hallucinations, drowsiness or sleeplessness, convulsion, nausea and constipation. 3 Parents giving their young children these medicines are generally confused by the labeling of ‘children’s’ medicine and they do not look at the back of the box that gives greater detail of what age the medicine should and should not be used in. The survey director Dr. Matthew Davis said, “Products like these may work for adults, and parents think it could help their children as well. But what’s good for adults is not always good for children.”3 This article urges parents to carefully read labels on children’s cold medicines before giving them to their young child.

Scientific studies have not found evidence that children’s cold medicine is effective. According to the New England Journal of Medicine, since 1985 all the controlled studies for cold medicine in children under the age of 12 have shown that there is no meaningful difference between the active drug of a cold preparation and placebo. 4 Even with this scientific evidence, some manufacturing companies refuse to change their labels to say that patients under the age of 6 should not use.4 Instead they market that their products are “safe, effective, and pediatrician recommended.” 4 Parents often take this as truth and give the medicine to their young children.

I fully agree with this article that parents need to look more carefully at the labels on medicines, especially when administering it to children younger than 6. Health care provider recommendations have age limits on cold products for the safety of children. When these recommendations are ignored either by accident or on purpose, the child is being put at risk for serious adverse effects. The easiest and quickest way to get a recommendation is from a local pharmacist. Pharmacists will be able to interpret directions if the parents are confused and will be able to determine if the child will need to be seen by a physician.

There are limitations to the article in the fact that it is a brief statement on how parents give cold medicines to young children when they shouldn’t. It mentions how they received these results through a survey but the article did not say what the name of the survey was nor did it say much more about the survey other than it was given to 498 parents with children under the age of 3. It would be beneficial to see the questions on the survey in order to evaluate if the questions matched what the results were. Another limitation is that the article could have gone deeper into what medicines are misused the most, how often parents ask pharmacists for help, and other studies that have been completed on the use of cold medicines in young children. It could also mention what would be the next step for parents to take. Pointing out the misuse is a great first start, but giving another option of what parents could do would be helpful.

How many of you know parents who give their young child cold medicine because they think it’s safe?

What do you use or recommend for colds in kids under 4 with cough or cold?




1. Schaefer M, et al. Adverse Events From Cough and Cold Medications in Children. Official Journal of the American Academy of Pediatrics. 2008; 121: 783-787


2. Vernacchio L, et al. Cough and Cold Medication Use by US Children, 1999-2006: Results from the Slone Survey. Official Journal of the American Academy of Pediatrics. 2008; 122:323-329


3. HealthDay. Many Parents Give Kids Cold Medicines When They Shouldn’t, Survey Finds. U.S. News. April 23, 2013. Accessed October 2013.


4. Sharfstein, J. Over the Counter but No Longer under the Radar-Pediatric Cough and Cold Medications. The New England Journal of Medicine. 2007; 357:2321-224.



4 Responses to “Are cold medicines safe in young children?”

  1. Anna Smith Says:

    You did a great job at writing this blog post. It is very informative and well done. I don’t really know anyone with younger children that I talk to enough to know what they give their children for colds. Rather than cold medications, though, I would recommend mostly non-pharmacological treatment, especially since studies have shown that cold medications are not effective in children. The non-pharmacological treatment I would recommend would be things such as saline nasal drops, a humidifier, and plenty of rest and fluids. A cold is usually something that people can get over themselves in a few days, so the non-pharmacological treatment could make them feel a bit better and more comfortable. For children those medications can be dangerous. If the symptoms get too serious though, I’d rather have them consult a doctor beforehand or talk to their pharmacist.

    I definitely agree with you that parents should look more closely at the labeling of the products they are purchasing for their children, and not just for colds. A child’s safety is at risk with any medication when parents do not read the recommendations and warnings. Many parents don’t think to ask their pharmacist about how to use the medications properly. I think pharmacists should be looking for parents buying such products and throw out some recommendations without the parents even having to ask. This would help ensure safety of the children even more. Just to make parents aware of the risks, there should be more information available or advertised in pharmacies about the potential problems that could come from giving children cold medications.

    I also agree with you in that I wish there was more information about the survey sent out to those parents. It would have been nice to know what all the parents were asked and given a more in-depth response as to what they answered. Also, if the study had gone more in-depth into what medications are misused the most, it would be easier for pharmacists and doctors to correct the issue.

  2. Elizabeth Ledbetter Says:

    Maria, I really like this post and the information is both alarming and interesting. I am curious as well to know which cold medications were misused the most, and which potentially led to the most emergency room visits. I think we as future pharmacists can play a critical positive role in this process. We are behind the counters very close to the aisles where mothers and fathers shop for cold medicines. However, we often get so busy and distracted that the LAST thing we feel that we have time for is a discussion with a parent. If we set down our work for a moment and walked out to the aisles, we could have a huge impact on which medications parents chose .Sometimes reading labels isn’t the easiest when words like “diphenydramine” and “dextromethorphan” are on there. WE know what those words mean but a parent might not. It is vital that we venture out to the aisles, especially during cold season, to assist people in choosing products.

    I am curious about the products that are labeled safe and effective for use in young children. Because these products are regulated by the FDA, their labels must be approved. I don’t necessarily think that they could say the products are safe for children if, in fact, they really are not. Maybe these products have much lower doses of active ingredients or even alternative ingredients that are safe for young children.

    Overall, great post! This definitely encouraged me to be a better future pharmacist and to take the knowledge we have learned in self-care and use it to help patients!

  3. Olumami Amaye Says:

    This is very interesting article, you actually touch on the basis of cold medication, in United States today children normally have three to eight cold per year, it drive parents crazy. As a parent, I’ve to deal with the fact that our three or five years old are fighting cold, it sometimes makes me want to go nut. Because there no known cure for the cold virus, but the best thing to do is try non-pharmacological treatment. To prevent the spread of viruses such as those that cause the common cold, children are advised to wash their hands well and frequently, use instant hand sanitizers, cover their mouth and nose when sneezing, dispose of used tissues properly, avoid close contact with those that have a cold during the first two to four days of their infection, not share food or cups, use paper towels rather that shared cloth towels, avoid crowded areas ( daycare center) where cold germs are apt to spread, eat healthy, and get enough sleep.

    I seriously agree with you that parents should pay more attention to the labels on medicines, especially when administering it to children younger than six, because most cold medication are design for greater than six old. In the limitations, you said the article should’ve gone doper in listing what medicines that were misused the most. But in most cases some parents don’t have time and energy to stick around and ask a pharmacist question about cold medication. According to my understanding you can use phenylephrine HCl 2.5mg every 4 hours (max 15mg) per day; or Pseudoephedrine 15 mg every 4-6 hours (max 60mg) per day for children 2 to less than 6.

  4. Yevgeniy Solokha Says:

    I would also recommend nonpharmacological therapy for young children because the side effects of the medications can often outweigh the benefits. It is mostly geared towards helping the immune system fight the viruses responsible for the cold. That is why proper hydration and rest would be key.

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