CHPA: Children younger than 4 should not use OTC cough/cold medicines

October 8, 2008

The Consumer Healthcare Products Association (CHPA) said that the drug companies it represents are voluntarily changing product labels of cough and cold medicines to warn against use of these products in children younger than 4.

The Consumer Healthcare Products Association (CHPA) said that the drug companies it represents are voluntarily changing product labels of cough and cold medicines to warn against use of these products in children younger than 4.

The new labels will begin appearing with these medications during the 2008-2009 cough and cold season, the CHPA stated. Medications with the existing labeling, which indicate that these products should not be used in children younger than 2, should currently not be removed from shelves, according to the US Food and Drug Administration (FDA). Drug manufacturers consulted the FDA about the new label change.

The CHPA noted on its Web site that "dosing errors and accidental ingestions-not the safety of the ingredients themselves when properly dosed-are the leading causes of rare adverse events in young children" who take OTC cough and cold medications. The reasons for the current label change mirror those behind a CHPA announcement in October 2007, in which OTC cough and cold medicines labeled for use in children younger than 2 were being voluntarily withdrawn from shelves by 14 drug manufacturers.

For more information on the current label change, visit the CHPA Web site here.