FDA Approves Children's Advil For Over-the-Counter Use

Parents Now Have a New Non-Prescription Option for Treating Their Children's Fever and Pain

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MADISON, N.J., June 28 /PRNewswire/ -- Children's Advil(R) (pediatric ibuprofen) was approved for marketing as an over-the-counter medication by the U.S. Food and Drug Administration (FDA), Whitehall-Robins Healthcare announced today. Children's Advil is indicated for the temporary relief of fever and the minor aches and pains due to colds, flu, sore throat, headache, and toothache for children two to eleven years of age.

"Since its introduction in 1989, more than seven million prescriptions have been written for Children's Advil Suspension, indicating its acceptance by both physicians and consumers as a safe and effective fever reducer and pain reliever," said Terry Stecz, President, Whitehall-Robins Healthcare. "The recent over-the-counter status of Children's Advil gives parents another choice for treating their children's symptoms and builds upon the heritage of the Advil(R) brand -- the #1 brand of ibuprofen for adults."

Children's Advil offers parents several benefits, including a convenient and effective dosing schedule, demonstrated safety profile, and a delicious fruit-flavored taste.

"Children's Advil is very effective at reducing fever and can be administered every eight hours, unlike Children's Tylenol(R) (acetaminophen), which must be taken every four hours to reduce fever," said Lorraine Stern, M.D., associate clinical professor, UCLA Department of Pediatrics. "Parents can use Children's Advil and feel confident that the child's fever will stay down for up to 8 hours. Their child can take a dose at bedtime and sleep through the night."

In addition to the benefits associated with Children's Advil's convenient dosing schedule, the product has an excellent safety profile, as demonstrated in a recent study of over 83,000 patients in 'The Journal of the American Medical Association.'

Furthermore, published reports of accidental overdose show that children taking up to 44 times the recommended dosage of ibuprofen often experience no adverse side effects. In contrast, acetaminophen has been shown to produce liver toxicity when taken in excess of just 15 times the recommended dosage.

"Many parents are concerned about the dangers associated with inadvertently giving their child too much medication," adds Dr. Stern. "Children's Advil's excellent safety profile can offer parents additional peace of mind regarding their medication choices for their children."

Children's Advil will be available in retail stores soon.

Whitehall-Robins Healthcare, a division of American Home Products Corporation (NYSE: AHP), is a leader in the research and development, manufacturing end marketing of a broad range of consumer healthcare products, with U.S. sales of approximately $1.5 billion. The company's broad lines of nutritionals and over-the-counter medications include many well known brands such as Robitussin(R), Dimetapp(R) and Advil, the leading adult ibuprofen. Advil -- with an 11-year history of proven efficacy and safety as an over-the-counter analgesic for adults -- is recognized in the development end distribution of health and fitness information for consumers and medical professionals, through the Advil Forum on Health Education(TM).

American Home Products Corporation is one of the world's largest research-based pharmaceutical and healthcare products companies and is a leading developer, manufacturer and marketer of prescription drugs and over-the-counter medications. It also is a leader in women's health products, vaccines, generic pharmaceuticals, biotechnology, agricultural products, animal healthcare, medical devices, infant nutritionals and food products.

CONTACT: Carol Dornbush of Whitehall-Robins Healthcare, 201-660-6923; or Christine Cramer of Edelman Medical Worldwide, 212-704-8185