Tylenol urges industry to follow its lead on voluntary alcohol labeling.

FORT WASHINGTON, Pa.--(BUSINESS WIRE)--March 7, 1996--McNeil Consumer Products Company, the makers of TYLENOL today launched a public information campaign to address misinformation delivered in a recent American Home Products television commercial for ADVIL, its brand of ibuprofen. McNeil has taken its concerns about the advertisement to the U.S. Food and Drug Administration (FDA) and to the television networks.

McNeil said the ADVIL advertisement, which shows a close-up of the alcohol warning on TYLENOL, fails to acknowledge that the manufacturers of all pain relievers, including ADVIL, have been urged to include an alcohol warning in their labels.

In 1993, FDA Advisory Committees recommended that all over-the-counter (OTC) pain relievers (analgesics) carry an alcohol warning. In January of 1995, Michael Weintraub, M.D., head of the FDA office overseeing OTC pain relievers, announced that the FDA will "...require an alcohol warning on all analgesic drugs. The alcohol warning will be for aspirin, ibuprofen, naproxen sodium, acetaminophen and combinations and non-aspirin salicylates."

McNeil said it is concerned that the ADVIL commercial may cause confusion. Some consumers could inappropriately switch to other OTC pain relievers which could potentially expose them to greater risks, including gastrointestinal ulceration and bleeding.

An American College of Gastroenterology study showed that patients are more than four times as likely to develop severe gastrointestinal bleeding if they consume alcohol and take NSAIDs (aspirin, ibuprofen, and naproxen sodium).

McNeil's public information program, which clarifies the issues surrounding the alcohol warning, will include statements placed in newspapers and magazines, national television announcements, and a nationwide mailing to doctors and pharmacists. McNeil is also making a toll-free hotline available to consumers.

The consumer information program is intended to minimize the public health risk during the interim period before the FDA finalizes labeling on all other OTC pain relievers.

McNeil said that in compliance with the FDA committees' recommendation, McNeil voluntarily added the alcohol warning to the entire line of adult TYLENOL products. The warning was a precondition to FDA's OTC marketing approval of three recently introduced nonsteroidal antiinflammatory drugs (NSAIDs): ALEVE, ORUDIS KT (also marketed by American Home Products), and ACTRON. The warning was also a precondition for marketing of TYLENOL Extended Relief.

The company said this warning still does not appear on the labels of aspirin or ibuprofen (the active ingredient in ADVIL) products. Nor has it been included on the labels of many of the other products containing acetaminophen (the active ingredient in TYLENOL) such as BAYER SELECT and many private label/store brands of acetaminophen.

McNeil urged the manufacturers of ADVIL, aspirin, and all other pain relievers that still do not carry the warning to take steps to ensure consumer safety by voluntarily adding an alcohol warning to their labeling.

McNeil emphasized that no drug is without potential side effects. Consumers should take the time to read all medication labels carefully and completely and to consult their physicians and pharmacists anytime they have questions.

McNeil Consumer Products Company is an affiliate of Johnson & Johnson.

CONTACT: McNeil Consumer Products Company

Ron Schmid

Office: 215/233-8146

Home: 215/230-5471

or

Jeff Leebaw

Office: 908/524-3350

Home: 908/821-6007