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Clearer Labels on Over-the-Counter Drugs Make Them Easier to Take

Oct. 13, 1999 (Washington) -- "Use only as directed" is the key to safe use of nonprescription drugs, says Philip D. Walson, MD, speaking here at the 69th Annual Meeting of the American Academy of Pediatrics. This recommendation can be remembered by following the anagram "SAFE": See the label, Ask questions, Follow directions, and Enter, or write down when and how much of a medication was taken, says Walson.

"There is a myth that if a medication can be bought without a prescription, it must be safe," says Walson, a professor of pediatrics and pharmacology at Ohio State University in Columbus, Ohio. "In reality, nothing that works is risk-free." Used properly, however, people can take over-the-counter (OTC) medications to get prompt relief of discomforts such as pain or fever, and to help them get on with their lives, he says.

Proper use of a drug goes beyond using it only for the use indicated, says Walson. The medication should only be taken at the dosage given on the label, and only for the amount of time indicated, he says.

Following directions should be easier now with new FDA guidelines for the labeling of nonprescription drugs, says R. William Soller, PhD. "We're trying to create a label that makes the advice we're giving easier to follow," he tells WebMD. "Generally, patients should remember to read the label and follow the directions, and to consult a health care professional if they have questions about a medication." Soller is the senior vice president and director of science and technology at the Consumer Healthcare Products Association in Washington.

These guidelines call for all nonprescription drugs to have the information regarding proper use in a clearly defined box and presented in a standard format. The information will include the brand name of the drug, the active and inactive ingredient or ingredients, the amount of those ingredients in a single dose, and the drug's purpose, for example "reducing fever." In addition, the use, or the types of illness or discomfort the drug is designed to treat, a section on warnings, addressing possible adverse reactions, when to stop using the drug, when to consult a physician, directions and a dosage chart are included.

Although patients and parents should be reasonably cautious when taking OTCs, they should also use common sense, says Walson. "Unfortunately, the goal of drug-free schools has made it difficult for children to receive medication for headaches in school health offices, or for daycare providers to apply sunscreen," he says. "We should not confuse drugs with legitimate medications. A simplistic approach is not helpful."

"These medications are generally safe and effective when used as directed," George S. Goldstein, MD, chair of the clinical pharmacology section of the American Academy of Pediatrics, tells WebMD in an independent interview. "In order to give them the respect and care they deserve, [people] need to read the label and ask questions."