OTC Cold Medicines to Be Relabeled for Young Children

Companies making over-the-counter cold and cough medicines have agreed to stop marketing the products to children younger than 4 as part of an effort to reduce accidental overdoses, an industry trade group said Tuesday.

The Consumer Healthcare Products Association, an industry group that represents makers of popular products like Robitussin and Triaminic, said cold and cough medicines will be relabeled to state that they should not be used in children younger than 4 at the urging of the U.S. Food and Drug Administration. Certain antihistamine products used to treat runny noses will be relabeled to warn parents not to use the products to sedate or make a child sleepy.

Linda Suydam, president of CHPA, said the relabeling is being done "out of an abundance of caution" and said the products are "safe and effective when used as directed."

It's the second time in a year that industry has agreed to limit marketing of cold and cough medicine to babies and young children. In October, industry said it would stop making various "infant" products and would relabel other products to state that they should not be used in children younger than 2. The move came after an FDA review of the products showed that most safety problems associated with the products were in that age group. The changes affect dozens of brand-name and generic products like Johnson & Johnson's Tylenol Plus Cold, Novartis AG's Triaminic and Wyeth's Robitussin. An estimated 95 million packages of children's over-the-counter cold and cough medicines are sold each year in the U.S.

More recently the FDA noted that most adverse-event reports were in children younger than 4, citing a study from the Centers for Disease Control and Prevention showing that two-thirds of about 7,000 emergency room visits annually associated with the products were from young children accidentally ingesting the products.

Read More