Cough, Cold Medicine Labels Will Exclude Young Children

摘要

Manufacturers of OTC children's cough and cold medicines are voluntarily changing labels to say the products should not be used in children younger than age 4, according to the Consumer Healthcare Products Association (CHPA). The FDA is investigating the safety and efficacy of these products and is not objecting to the labeling modification because it reflects a more cautious use of the drugs, the agency said during a conference call. Manufacturers will conduct studies to reaffirm the effectiveness of oral OTC pediatric cough and cold medicines, confirm appropriate dosing schedules and validate the efficacy of these medications, the CHPA says. Manufacturers also will introduce new measuring devices and child-resistant packaging for the products.