Are cold medicines safe in young children?

  1. About
  2. Pre-Pharmacy
  3. Pharm D
  4. Current Students
  5. Facilities
  6. Faculty and Staff
  7. Experiential Program
  8. Research
  9. Accreditation
  10. Gift Giving
October 17, 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.



Posted in: Allergies/Cold