Cold Medicine Warning: Do not Administer to Children Under Four Years of Age

Karen Gatlin

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Attention, parents: Don't give your children under 4 over-the-counter cough and cold medicines, and read the fine print on labels, say makers of such remedies who have been under pressure to strengthen their warnings. The cough and cold medicine industry, in the wake of intensifying criticism from consumer groups, lawmakers and pediatricians, agreed Tuesday to add "do not use" warnings to pediatric cough and cold medicines. The voluntary move by the Consumer Healthcare Products Association, which includes Johnson & Johnson, Wyeth, Novartis AG and Procter & Gamble among its members, follows earlier recommendations that products be banned for children under 6, saying they don't work and that the risks to kids outweigh the benefits.

The Food and Drug Administration, which advises parents against giving such medicines to children under 2, said it supports the move by the industry even while it has undertaken a highly publicized evaluation of cough and cold medicines. The FDA has yet to give its own guidance but worries that parents would give adult doses if it instituted a ban of products for children under age 6.