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McNeil, Wyeth supporting children’s cold medicine measures

Philadelphia Business Journal

McNeil Consumer Healthcare and Wyeth are among the pharmaceutical companies supporting a voluntary industry initiative to curtail sales of cough and cold medicines to children younger than 4 years old.

McNeil Consumer Healthcare of Fort Washington, Pa., a subsidiary of Johnson & Johnson (NYSE: JNJ), makes Children’s Tylenol, Children’s Sudafed, Children’s Benadryl and PediaCare cough and cold products. Wyeth (NYSE: WYE) of Madison, N.J., is the maker of Dimetapp and Robitussin cough and cold products.

The Consumer Health Products Association said Tuesday its members are rolling out new labeling for over-the-counter cough and cold products that advise against use of the products in young children to protect against adverse events.

The modified labels will continue to provide dosing information for children four and older.

“Children’s over-the-counter cough and cold medicines are safe and effective when used as directed, and the leading makers of these medicines are committed to working with the Food and Drug Administration and pediatric experts to ensure that parents and caregivers have appropriate treatment choices for their children,” read a statement released by the association. “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 announcement follows hearings held last week by the Food and Drug Administration to discuss safety issues associated with such over-the-counter products.


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