Over the Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing

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The Food and Drug Administration (FDA) is announcing a public hearing to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use. Many of these nonprescription cough and cold drug products are marketed under the OTC Drug Review, which established a monograph describing the conditions under which certain OTC ingredients are considered to be generally recognized as safe and effective. Recently, safety and efficacy concerns have been raised regarding the pediatric dosing and use of certain active ingredients in OTC cough and cold drug products. FDA is developing a proposed rule to revise the pediatric labeling contained in the Final Monograph for Cough, Cold, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. At this public hearing, FDA is interested in obtaining public comment about certain scientific, regulatory, and product use issues as it proceeds with the rulemaking and reviews new drug applications (NDAs) for these ingredients. Dates and Times: The public hearing will be held on October 2, 2008, from 8 a.m. to 5 p.m. Location: The public hearing will be held at the Sheraton Washington North Hotel, 4095