DOCTOR'S VIEW ARCHIVE
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
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:
"This proposal is the latest effort by FDA to
give consumers accurate, reliable information about products that
affect their health," said David A. Kessler, Commissioner
of Food and Drugs.