Effect of cough and cold medication restriction and label changes on pediatric ingestions reported to United States poison centers

J Pediatr. 2013 Nov;163(5):1372-6. doi: 10.1016/j.jpeds.2013.04.054. Epub 2013 Jun 12.


Objective: To determine the impact of industry and Food and Drug Administration initiatives implemented to limit the use of over-the-counter (OTC) cough and cold medications in children younger than 6 years of age.

Study design: This is a retrospective database study of OTC cough and cold medication ingestions reported to US poison centers between 2000 and 2010. Data analyzed from the National Poison Data System included the month and year of ingestion, reason for ingestion, health care utilization, and medical outcome. Ingestion frequencies were stratified by age and reason. Data were divided into pre- and postintervention periods for comparative analysis.

Results: Unintentional ingestions of OTC cough and cold medications decreased 33.4% and therapeutic errors by 46.0%. Health care facility referral declined for unintentional ingestions (28.9% <2 years of age, 19.9% 2-5 years of age, P < .0001) and therapeutic errors in children younger than 2 years of age (59.2%, P < .0001). Moderate and severe adverse outcomes decreased for unintentional ingestions in children younger than 2 years of age by 32.4% and by 21.3% in 2- to 5-year olds, P < .0001.

Conclusions: The restriction of OTC cough and cold medications has led to a decline in unintentional ingestions, therapeutic errors, health care facility referral, and serious medical outcomes in children younger than 2 years of age. There has also been a decline in ingestions in 2- to 5-year-old children.

Keywords: CHPA; Consumer Healthcare Products Association; FDA; Food and Drug Administration; NPDS; National Poison Data System; OTC; Over-the-counter.

MeSH terms

  • Antitussive Agents / poisoning*
  • Child
  • Child, Preschool
  • Cough / drug therapy*
  • Databases, Factual
  • Drug Labeling*
  • Expectorants / poisoning
  • Histamine Antagonists / poisoning
  • Humans
  • Infant
  • Nasal Decongestants / poisoning
  • Nonprescription Drugs / poisoning*
  • Patient Safety
  • Poison Control Centers*
  • Poisoning / epidemiology*
  • Retrospective Studies
  • Treatment Outcome
  • United States
  • United States Food and Drug Administration


  • Antitussive Agents
  • Expectorants
  • Histamine Antagonists
  • Nasal Decongestants
  • Nonprescription Drugs