McNeil relabeled Children's Tylenol to be launched in early 1998; Be SAFE campaign starts.

McNEIL "BE SAFE" WITH CHILDREN's OTCs MATERIALS GOING OUT TO 95,000 child care professionals. The J&J company's "Be SAFE" consumer education program is an "expansion of [McNeil's] KidCare bilingual consumer-education program designed to inform parents about the safe use of children's over-the-counter medications," the marketer of Children's Tylenol announced Dec. 10.

The program's 1.5 mil. posters, tip cards and flyers are being distributed to consumers through 50,000 pharmacists, 20,000 daycare centers and clinics and 25,000 doctors nationwide. "The program delivers four important messages through the letters in the word `SAFE,'" the company explained. The messages are: "S...See the label for complete instructions..., A...Ask a doctor, pharmacist or other health care professional if you have questions..., F...Follow the directions carefully..., and E...Enter the time and amount of each dose."

The advice offered in the Be SAFE campaign closely resembles a "public service announcement"-type print ad McNeil plans to run during the first quarter of 1998 ("The Tan Sheet" Oct. 27, p. 4). The company announced the PSA and the relabeling effort following the Sept. 18 meeting of FDA's Nonprescription Drugs Advisory Committee on the labeling of OTC pediatric analgesic/antipyretic drug products ("The Tan Sheet" Sept. 22, pp. 1-3). The committee recommended that FDA require changes to labeling for OTC pediatric analgesic/antipyretic products to include dosing directions for children under the age of two.

The multicolored Be SAFE brochure features a bee with the accompanying caption, "When it comes to medication safety, follow the CareBee and Be SAFE." Following is the Be SAFE four-part message. The "See the label..." portion instructs the reader to "be certain you have selected the right product, understand the dosing instructions, and are aware of any warnings or precautions that may apply to your child."

The "Follow the directions..." section explains: "Do not exceed the recommended dose. Give only the amount indicated for your child's weight or age. If possible use weight to dose, otherwise use age. Always use the dropper, dosing cup, or other measuring device that comes with the medicine. Household items like kitchen spoons may not be accurate. Never use spoons, droppers, or cups that come with other medicines."

The backside of the brochure explains, "Infants' and Children's Tylenol come in different concentrations so they can be given more easily to children of different ages." The Be SAFE brochure notes that "Infants' Tylenol Concentrated Drops are more concentrated than Suspension Liquid or Original Elixir."

McNeil is in the process of relabeling Children's Tylenol and expects to have the revised labels on shelves by the beginning of the year.

The modifications will include a change to the front panel of the infant drop formulation to read "Concentrated Drops" rather than "Suspension Drops," inclusion of the phrase "read instructions carefully" on the front panel of all Children's Tylenol products and "increased emphasis of the importance of using the specific dosing device that comes with the dosage form (e.g., dropper or cup)."

The new labeling also will include the warning: "Taking more than the recommended dose (overdose) will not provide more pain or fever relief and could cause serious health risks." An Oct. 18 wire service story that received wide attention by the lay media suggested small overdoses of acetaminophen may have caused liver damage and death in children, but added that McNeil "for the first time" would include warnings against such overdosing on its children's products. In addition, a study in the Oct. 16 issue of the New England Journal of Medicine concluded that acetaminophen doses of 2 g-30 g increased morbidity and mortality among acetaminophen-overdose patients ("The Tan Sheet" Oct. 27, p. 5).

The Be SAFE program is being conducted in conjunction with the American Pharmaceutical Association. McNeil noted "each year, we distribute an estimated 10 mil. KidCare educational pieces through doctor's offices and pharmacies," adding, the Be Safe initiative "enables us to reach an even larger population of parents."

Aside from the posters, tip cards and flyers, a video news release is also available for broadcast. The Be SAFE brochure includes a 50 [cents]-off coupon good for any size of Children's Tylenol (except trial size) that is good through Dec. 31, 1998. The materials include a 1-800-number through which healthcare professionals can order materials; consumers interested in obtaining a copy of the materials through McNeil are being asked to contact the company's Consumer Affairs division.