Many Seniors in Study Find Labels on Tylenol Unreadable

Three doctors from the Southern California College of Optometry have found that 29% of senior citizens they studied could not read the label on the popular painkiller Tylenol and so risk take an improper dose.

Print size on the popular painkiller’s label on the 50-tablet bottle was small and “inadequate,” the researchers said. Further, Tylenol’s manufacturer “crammed” so many letters together--53 letters per inch, compared to 30 per inch on an Advil bottle and 38 per inch on a Thrifty aspirin bottle--that the characters “blurred” into one another and were hardest to read, said study co-author Marilyn Gilbreath.

The study, which looked only at over-the-counter drugs, suggested that elderly people with failing eyesight can overdose on poorly labeled drugs or take a dangerous combination of drugs by mistake.

Gilbreath, chief of low-vision rehabilitation services at the Fullerton college, and fellow authors Christine Sakamoto and Ronald Watanabe will present their research today at the Disneyland Hotel before several thousand optometrists at the annual meeting of the American Academy of Optometry.

Gilbreath and her fellow researchers are seeking new state and federal regulations requiring readable labels on over-the-counter drugs.

A 1990 California law asked non-prescription drug makers to improve their labels but failed to mandate any improvements, said Gilbreath, who added, “There was no teeth in the bill whatsoever.”

But California food and drug officials said they believed non-prescription drug makers were making significant changes because of that law. Their trade group, the Nonprescription Drug Manufacturers Assn., recently reported that “93% (of its 85 members) had formed a committee and have a corporate agreement that there is a problem. . . . And 60% of them have made major changes” in their labeling, according to John Wallace, a state drug division scientist.

The manufacturers of Advil, Tylenol and Thrifty aspirin only learned of the labeling study Friday and had mixed responses. All said they recognized that to use their product safely, consumers need readable labels. But they said that as part of a voluntary national campaign by the non-prescription drug industry that began this year, they were working hard to improve their labels and no new government regulations were needed.

“We’re working on relabeling right now,” said Edwin C. Watson, spokesman for McNeil Consumer Products in Ft. Washington, Pa., which manufactures Tylenol.

As to the alleged danger of illegible drug labels, Watson noted that Tylenol has been on the market since 1960, and “we have had no reports that somebody has overdosed because they couldn’t read the label.”

Watson also complained, “To me, if the tests (in the Fullerton study) were completely fair, they would have all been designed (using) the same size box.”

To highlight labeling differences, the Fullerton researchers compared a small 50-caplet bottle of Regular Strength Tylenol (the trade name for acetaminophen), with a larger, 100-caplet bottle of Advil (the trade name for ibuprofen), and a larger, 60-tablet bottle of Thrifty’s Maximum Strength Arthritis Relief (coated aspirin).

Ninety-two seniors over age 60 attempted to read the Advil and Thrifty labels and 77 attempted to read the Tylenol label. All seniors were able to read the Advil label, six were unable to read the Thrifty label at all and 22 were unable to read the Tylenol label, the Fullerton researchers said.

Karen Richards, spokeswoman for Advil’s manufacturer, Whitehall Laboratories of New York City, said her firm is “very aware of the issue” of readable labeling and is relabeling products right now.

“We’re ready to begin making changes, including making the type larger and using dark type on white backgrounds,” said Richards, whose firm is participating in the voluntary national labeling campaign.

At Thrifty, public affairs assistant Rebecca Vaidman said her company’s private label buyers and vendors “make a conscious effort to make all labels readable for the safety of the consumer.” She noted that California law requires the firm “to present several warnings on our labels. . . . We have a small bottle so we’re going to have smaller print,” Vaidman said, “but we do want to have consumers’ safety first.”

Still, she called the Fullerton study “very interesting. Our senior citizens are a population that does require more medication and we do need to be aware of their needs.”

The Fullerton study was prompted by a 1989 proposal from the state’s Senior Assembly representing seniors around the state, which asked the Legislature to enact a bill requiring readable labels. In addition to the general interest by seniors in the issue, concern was reportedly heightened when Robert Jaffe, the San Jose senior representative, was unable to read a warning on an over-the-counter drug label. Jaffe took the medicine and “almost died,” said Edward Kramer, a representative from Marin County.

The seniors’ lobbying produced a bill, signed into law Sept. 12, 1990, that asked manufacturers to evaluate and modify the labeling of over-the-counter drugs to make the labels more readable and report progress to the Legislature quarterly, until December, 1993.

Interested in the issue, assistant professor Gilbreath and her co-authors decided in July, 1990, to do their own study.