FDA Proposes Easy-To-Understand OTC Labels

WASHINGTON-Accurate and clearly-understandable drug labeling plays an important role in the proper administration of medications. Currently, no universal labeling system is used on the drugs obtained without a prescription (over-the-counter drugs).

FDA yesterday proposed new, greatly improved labels for drugs on which Americans depend for the vast majority of their day-to-day health care needs. The new labeling of over-the-counter (OTC) drugs, for which consumers spend $18 billion a year, will provide consumers with easier-to-read and understand information about the products' benefits and risks, and how they should be used.

"Today's action is important for anyone who ever takes a pain reliever, cough syrup or any of the thousands of other over-the- counter items on the market," said Donna E. Shalala, Secretary of Health and Human Services. "The information on the new, much more understandable labels will help consumers to choose the right medication and avoid harmful mistakes."

The main provision of the proposed regulation involves the new label format. Its main features include:

  • Uniform, standardized headings, subheadings and a standardized order of information
  • Simplified language for certain words or phrases, for example: "throw away" instead of "discard"; "lung" instead of "pulmonary"; "hole in" instead of "perforation of"
  • A new bulleted, easier-to-read format, including a minimum type size and type style

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