Should You Recommend OTC Cough and Cold Meds to Kids?

I’ve always been slightly confused about exactly which over the counter cough and cold medications I should recommend to my patients. There are just so many products on the market. Which ones actually work? Not to mention, it seems like the guidelines for products marketed to patients, especially in pediatrics, are ever-changing. So, what’s a nurse practitioner to do?

Back to school season is upon us which is naturally followed by colds, the flu and other communicable diseases. In anticipation of treating the sniffles, I’ve gathered some helpful background on over the counter products to inform us nurse practitioners as we embark on the coming months. Today, let’s talk pediatric guidelines. Should we recommend OTC cough and cold medications to children? When?

To understand the guidelines about OTC cough and cold medications in children, a brief history is helpful. Here’s how we got to the state of confusion we’re in today. 


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Not only did Jimmy Carter win the presidential election and the film Rocky hit the big screen in 1976, the year also set the stage for the booming over-the-counter cough/cold medication market we have today. An FDA advisory panel convened, endorsing the use of a number of OTC ingredients for cough and cold symptoms. Given that there was ‘negligible or nonexistent’ data on pediatric use of these drugs, the committee arbitrarily recommended against use of these medications for children under two years of age. For children over the age of two, the FDA suggested a crude formula for extrapolating pediatric doses based on those for adults. For example, the panel suggested that children between 6 and 11 years of age should be administered half of an adult dose and that children ages 2 to 5 years should be administered one quarter of the adult dose. 

The FDA made these recommendations, but permitted manufacturers to market OTC cough and cold preparations to children below these ages as long as labels instructed parents to ‘consult a doctor before use’. Guidelines were implemented but not reviewed or called into question for the next 30 years. 


The band Hanson’s song ‘MMMBop’, Will Smith’s ‘Men in Black’ and Backstreet Boys’ ‘Quit Playing Games’ were all chart topping hits in 1997. A lesser known public declaration from the American Academy of Pediatrics also came to light. The organization called attention to long neglected OTC cough and cold medication guidelines stating that “indications for their [cough/cold medications] use in children have not been established”. Although the group issued this warning, little was done at the time to modify regulations and guidelines. 

2000 – 2006 

While Y2K did not have the disastrous consequences that doomsayers predicted, things were taking a turn for the worse on the OTC medication front. From 2000-2007, poison control centers reported more than 750,000 calls related to concerns about cough and cold products. From 2004-2005, the Centers for Disease Control identified more than 1,500 emergency room visits for children under 2 years of age who had been given cough or cold products. In 2006, the American College of Chest Physicians echoed sentiments of pediatric organizations stating that “literature regarding over-the-counter cough medications does not support the efficacy of these products in the pediatric age group”. 


With questions about the safety and efficacy of cough/cold preparations looming, in March 2006 a group of medical experts filed a petition asking the FDA to issue a public statement outlining that ‘these products have not been shown to be safe and effective in children under six years’. Since 1985, studies of these medications had not shown any meaningful benefit in children under 12 years of age. 

The FDA responded in November of that year by hosting a meeting of the Pediatric Committee and the Nonprescription Drug Advisory Committee. Days before the meeting, major manufacturers voluntarily recalled OTC cough and cold preparations for children under two years of age. 

In the meeting of these committees, participants voted 13 to 9 in favor of immediate action against the use of cough and cold medications in children under six. Manufacturers struck back stating they disagreed with the committee’s conclusions and would continue to market these medications for children between two and five years. Many labels were modified to include language stating “do not use in children under 4 years” although ‘toddler’ formulations and marketing to young patients persisted. The FDA praised the inclusion of this warning label.

Overall, the production of cough and cold medications for the pediatric population continues to be permitted despite evidence that these medications are ineffective and can have a questionable safety profile. 

What’s the result of these changing guidelines, manufacturer marketing decisions and lack of evidence about the safety and efficacy of OTC cough and cold medications? Confusion! 

Should nurse practitioners recommend OTC cough and cold medications for kids? 

Overall, evidence is lacking for the efficacy of cough and cold medications in children. Antipyretics like Tylenol and Motrin can be helpful for reducing fever and relieving illness-associated aches. But, when it comes to antitussives, expectorants and antihistamines studies don’t show that these medications have significant benefits (Schroeder & Fahey, 2004). One exception is decongestants. In children 12 years and older, OTC decongestants like phenylephrine and pseudoephedrine may provide relief of nasal symptoms. For the most part, you’ll want to stick to recommending supportive measures and reminding parents of the harried timeline of OTC cough and cold medication guidelines. 


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