Theres a simpler substitute for the word assistance: help.

For discard: throw away.

And for aggravate: make worse.

Soon, consumers could see the plain-speaking terms in place of longer, harder-to understand ones on everything from aspirin for aches and pains to zinc chloride for canker sores. A new Food and Drug Administration regulation allows these pairs of words and some others to be used interchangeably on the labels of nonprescription, or over-the-counter, drugs.
In addition to permitting some word swaps, the new rule requires that all OTC drug labels contain certain information-such as ingredients, doses and warnings-in a standardized format.

The rule, published in the March 17, 1999, Federal Register, covers some 100,000 nonprescription products, including those like sunscreens that have both drug and cosmetic uses. The goal of the uniform label is to help consumers understand a nonprescription drugs benefits and risks and take the medicine correctly.

The new rule, said Vice President Al Gore when he announced it March 11, will ensure that the labels on medicine we buy over the counter are no longer written in language that is over our heads. Starting here and now, when children wake up sick in the middle of the night, parents wont have to read a dictionary to read the directions. And people wont need a magnifying glass to find out whats in their medicine.

FDA hopes the new Drug Facts labels will improve the way consumers choose and use over-the-counter medicines just as the simplified Nutrition Facts labels have helped consumers eat less fat and otherwise improve their eating habits.

People have told us, and studies have confirmed, that the food labels are working, says Peter Rheinstein, M.D., director of the medicine staff in FDAs Office of Health Affairs. Whats lacking in many OTC labels is readability, consistency--all the things the new food label has. Its not that the information isnt there already. Sometimes its just hard to find.

Debra Bowen, M.D., who led the FDA team that wrote the regulation, sees the similarity with the standardization of the food label, and adds that using a drug correctly requires even more elaborate information about risks and benefits So its all the more important Bowen says to provide not only complete information about drugs but complete information in a readable, clear and simple format.
Just the facts
Americans buy about 5 billion over-the-counter drugs each year, accorning to government estimates, to treat their headaches, heartburn, coughs and colds, and other routine health problems. According to the Consumer Healthcare Products Association, a trade group that represents nonprescription drug makers, more than 600 OTC drugs contain ingredients and dosages that 20 years ago were available only by prescription. Over-the-counter drugs are very safe as a rule. but not risk-free, Rheinstein says.

Just because omething is sold ov er the counter, he says doesnt mean its absolutely safe. Any medicine thats strong enough to help you also has the power to hurt you if you dont take it right.

Taking a medicine right can help avoid dangerous adverse reactions, its true, but Rheinstein adds that a Person who uses a medicine incorrectly can be harmed in another important, although perhaps less dangerous, way:

If you buy a drug without having all the information, you may not get all the benefit it can provide, he says. The new rule will help people get all the benefit they re pay ing for.

The new labels simple language and easy-to-read format should help people compare drug products to choose the best one to treat their illness, get the drugs full benefit and avoid unnecessary adverse reactions.

Under the rule, OTC drug labels must Comply with these requirements:

" Information Must be presented in a standardized, easy-to-follow format, usually on the packages outside container or wrapper. Under the title Drug Facts, the products active ingredients will be listed first, along with the purpose for each, followed by uses, warnings, directions. and inactive ingredients. Listing inactive ingredients is a new requirement, that should help consumers avoid products that may cause an allergic reaction. Also, FDA recommends, hut doesnt require, that manufacturers include a phone number on the label for consumers to call for more information.

" Simple language must be used to critical information, such as a drugs ingredients, dose and wanrnings. For example. the term uses replaces indications, and some other technical words like precautions and contraindications wont be used anymore. either. Studies have shown that consumers often hare difficulty using the information as currently presented on OTC drugs. One study, for example, reported that 70 percent of caregivers could not measure the correct dose of medicine for their child, a problem that puts that child at risk of being overmedicated or undermedicated.

" The label must he printed in type large enough to be easily read and use other graphical methods to improve readability, such as bullets, a certain amount of spacing between lines, and thin lines separating label sections. Studies have shown that many older Americans in particular cant read the small type on some current labels. This increases their risk of taking the wrong dose of a medicine or taking a medicine that could be harmful if combined with another drug they are using.