Children's Cough and Cold Medicines

CHPA supports the safe and effective use of pediatric cough and cold medicines for children age 4 and older.

PediatricCCFor decades, millions of parents and caregivers have trusted and relied upon over-the-counter (OTC) pediatric cough and cold medicines to provide relief and comfort to children suffering from common cold symptoms such as runny noses, congestion, and cough. Having around-the-clock, over-the-counter availability of these medicines helps parents to relieve their children’s symptoms day and night. In fact, according to a Center for Medicine in Public Interest (CMPI) survey, an estimated 8.5 million households in the past 12 months have children aged 4 and older who have avoided missing school or daycare due to illness because their parents had access to OTC cough medicines to treat their cough symptoms.

These medicines are proven safe when used as directed for children age 4 and older. Serious adverse events are rare. When they do occur, data show that the vast majority are from accidental, unsupervised ingestion—curious young children getting in to medicine that was left out in an accessible place.

Initiatives to Promote Safe and Responsible Use 

Manufacturers have proactively invested in packaging and labeling improvements, parent and healthcare provider education, and continued research to support the responsible use of children's cough and cold medicines and reduce accidental unsupervised ingestions. These include:

  • Facilitating dosing and ingredient recognition: To aid parents’ ability to choose and use the right medicine, manufacturers now package each liquid pediatric cough and cold product with an accompanying dosing device, and list all active ingredients on the front of the package [i.e., principal display panel or PDP].
  • Monitoring safety data to identify the root cause of reported adverse events: In 2008, manufacturers set out to better understand why a small percentage of children have adverse reactions involving these medicines. An independent, comprehensive four-year study shows that the vast majority of serious adverse events, or overdoses (75 percent), involve a child getting into medicine when a parent or caregiver wasn’t looking. This study looks at all pediatric adverse events, including cases reported to member companies, the U.S. Food and Drug Administration (FDA), and poison centers, medical literature, and other verifiable sources. The research shows that dosing errors and accidental ingestions—not the safety of the ingredients themselves when properly dosed—are the primary causes of rare adverse events in young children.
  • Expanding the body of scientific studies: In 2008, manufacturers also committed to expand the body of evidence supporting use in children, specifically. We have already developed new tools needed to objectively measure children’s symptom relief and have begun clinical efficacy studies using these tools, beginning with nasal decongestants and a cough suppressant. We expect efficacy trials to run for several years, in a sequenced order.
  • Educating parents and caregivers: Manufacturers, together with FDA and the Centers for Disease Control (CDC) and a host of healthcare providers, conduct ongoing education to promote safe storage and safe use. The CHPA Educational Foundation, partners with CDC and FDA on the award-winning Up and Away and Out of Sight campaign to remind parents to store medicines safely to prevent accidental ingestion. The foundation also promotes medicine safety information and videos for parents on its KnowYourOTCs website and conducts annual Treat with Care educational campaigns during cold and flu season to reinforce the safe use of cough and cold medicines, underscoring our members’ voluntary labeling “do not use” in children under age 4.
  • Adding new warnings:  For products containing certain antihistamines, manufacturers voluntarily added new language to the Drug Facts Label in 2008 that warns parents not to use antihistamine products to sedate or make a child sleepy.
  • Clarifying the appropriate age of use:  To help prevent some rare patterns of misuse and misdosing that previously led to overdose in very young children—and to address the accidental unsupervised ingestion issue—manufacturers  voluntarily withdrew products for children age 2 and younger in 2007. In 2008, industry voluntarily transitioned the labeling on oral OTC pediatric cough and cold medicines to state “do not use” in children under 4 years of age.

The vast majority of parents and caregivers safely use these medicines to help relieve their children’s symptoms. But as with all medicines, it’s important that parents read OTC medicine labels carefully, use these medicines only as directed, and store them up and away and safely out of the reach of children.

FDA is currently reviewing the safety and efficacy of pediatric cough and cold medicines and is expected to issue rulemaking in the near future.


Related links: