Drugmakers begin relabeling cough/cold meds for kids



October 13, 2008 -

Members of Consumer Healthcare Products Association (CHPA), Washington, DC, embark on voluntary effort to relabel over-the-counter cough/cold medicines. Change involves nearly 50 products formulated for children, brand names such as Tylenol®, Pediacare®, Sudafed®, Benadryl®, Triaminic®, NyQuil®, Vicks®, Delsym®, Mucinex®, Dimetapp®, Robitussin®. New labels state “do not use in children under 4” years of age. In addition, products containing certain antihistamines warn parents not to use products to sedate or make child sleepy. If not already present, liquid products add child-resistant packaging, measuring device to reduce chances of accidental ingestion, misdosing, the leading causes of adverse events in young children. US Food and Drug Administration (FDA), Washington, DC, supports voluntary action by CHPA members to help prevent, reduce misuse, provide better information to caregivers. FDA continues to assess safety, efficacy of these products. Although new labeling is inconsistent with current monograph (list of approved ingredients, amounts), FDA plans no objection to “do not use in children under 4” instructions, which reflect more restrictive use.



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