Children under the age of 4 should not be given over-the-counter (OTC) cold remedies, according to new labeling being prepared by leading cold medicine manufacturers.

The manufacturers of medicines sold under brands such as Dimetapp, Pediacare, Robitussin, Triaminic and Little Colds have agreed to voluntarily change their labels to state “do not use” for children under 4. In addition, manufacturers of products containing antihistamines will add language to their labels warning parents to refrain from using these medications to induce drowsiness in young children.

The changes came following consultation with the Food and Drug Administration, which earlier this year recommended that children younger than 2 years old should not be given cold medications.

Children’s cough and cold medications are safe and effective when used as directed, stressed the Consumer Healthcare Products Association (CHPA), the trade group that announced the voluntary labeling changes. “Research shows 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,” the CHPA stated.

Indeed, a study by the Centers for Disease Control and Prevention, which concluded that thousands of young children are hospitalized annually after ingesting cough and cold medicine, also determined that the vast majority of children hospitalized had taken medication while unsupervised.

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