Labels for OTC Drugs Required to be Simpler, More Legible

The Clinton administration has announced a new rule requiring easier-to-read labels on cough syrup, pain relievers, cold remedies and other over-the-counter medications. The labels on all non-prescription drugs will feature a standardized format for label information, larger print size, more white space and clearer language and are expected to start appearing on products within weeks. Drug makers will be encouraged, though not required, to simplify some of the language used, such as substituting "lung" for "pulmonary" and "throw away" for "discard."

The regulation is aimed at preventing an estimated 178,000 hospitalizations every year that result from consumer confusion or failure to read carefully about the products. These hospitalizations frequently occur among the elderly, whose vision may be poor or who may be taking multiple medications that can cause adverse reactions.

Much like the food labels that now require a detailed listing of calories, fat content and other nutritional information, the labels on 100,000 over-the-counter drugs are expected to be very popular among users. The new proposals are supported by the nonprescription-drug industry, which has been working with the Food and Drug Administration for several years to redesign the labels, and by many consumer and senior citizens' groups. An official of the Nonprescription Drug Manufacturers Association, which represents the industry, described the group as "very pleased" with the outcome, and Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, predicted that revising the labels would be "an important step forward, just as it has proven to be with foods."

Americans spend $18 billion to $20 billion annually on over-the-counter drugs. The FDA has estimated the changes would cost the industry about $58 million and could save $140 million if it succeeds in eliminating many unnecessary hospitalizations. The elderly make up 13% of those buying over-the-counter drugs but consume about 25% of all nonprescription medications, the drug industry said.

Standard Headings, Subheadings
The regulation requires standard headings and subheadings and dictates the order of information. For example, a label would first list the active ingredients and purpose of the drug and then cite its different uses. This would be followed by specific warnings, including descriptions of when to consult a doctor before using the medication, interactions with other drugs and potential side effects. Finally, the directions for use, including dosages, would appear boxed on the bottom of the label.

Additional information would be provided on a side panel. This would include such facts as how to store the product — at what temperature, for example, and advice such as "protect from excessive moisture" — and a list of the drug's inactive ingredients, such as colorings or preservatives. The latter would be especially valuable for consumers who have allergies or sensitivities to these substances.

The format itself would be streamlined, with an easier-to-read design and a minimum 6-point type size. Some smaller packages would be allowed to modify certain graphic elements — the bold lines that make up the box, for example — to accommodate the required new larger type size.

In 1990, California approved legislation asking manufacturers of over-the-counter drugs to make their labels more readable, but many groups complained the law has no teeth because the changes were not mandatory. The new federal rule will prevail over state actions. The new label will begin appearing this spring on some products and will be on most within two years.