MCNEIL CONSUMER HEALTHCARE DIVISION OF MCNEIL PDI INC. IS VOLUNTARILY WITHDRAWING INFANTS’ COUGH AND COLD PRODUCTS:

· INFANTS’ TYLENOL® COLD DYE FREE DROPS
· BENYLIN® FOR INFANTS’ COUGH AND COLD ORAL DROPS
· BENYLIN® FOR INFANTS’ STUFFY NOSE ORAL DROPS

Markham, Ontario, October 11th - McNeil Consumer Healthcare division of McNeil PDI Inc. announced today that the company is voluntarily withdrawing certain infants’ cough and cold products from the market. When used as directed, these medicines are recognized as safe and effective. While most parents use these medicines appropriately and follow dosing directions, an assessment of available data on the use of pediatric cough and cold medicines has identified rare instances of misuse leading to overdose, particularly in infants under 2 years of age.

McNeil Consumer Healthcare is withdrawing INFANTS’ TYLENOL® COLD DYE FREE DROPS; BENYLIN® FOR INFANTS COUGH AND COLD ORAL DROPS, AND BENYLIN® FOR INFANTS STUFFY NOSE ORAL DROPS from the Canadian market.

Cough and cold products for children age two and over and single-ingredient pain reliever/fever reducers expressly labeled for infants (TYLENOL® Infants’ Acetaminophen Drops and MOTRIN® Infants’ Ibuprofen Oral Drops) are not included in this voluntary withdrawal and remain available for parents and caregivers.

“This voluntary action by McNeil Consumer Healthcare is based on the company’s longstanding commitment to the appropriate use of medications by parents and physicians,” said Bill Murphy, General Manager OTC Business Unit Canada. “McNeil Consumer Healthcare is committed to providing parents with safe and effective over-the-counter medications that treat their child’s cough and cold symptoms. In addition to taking this voluntary action, McNeil Consumer Healthcare, along with our industry partners, supports the US Consumer Healthcare Products Association recommendations that were recently submitted to the U.S. Food and Drug Administration (FDA). These recommendations include label changes to OTC cough and cold medicines advising ‘do not use’ in children under 2 years of age. Our voluntary action in removing INFANTS’ TYLENOL® COLD DYE FREE DROPS; BENYLIN® FOR INFANTS COUGH AND COLD ORAL DROPS, AND BENYLIN® FOR INFANTS STUFFY NOSE ORAL DROPS from the Canadian market is consistent with these recommendations. McNeil Consumer Healthcare will consult with Health Canada concerning the implementation of the US Consumer Healthcare Products Association recommendations and any additional recommendations made by Health Canada following their review.

The recommendations that were submitted by the US Consumer Healthcare Products Association are intended to help reduce misuse leading to overdose by further promoting the appropriate use of OTC cough and cold medicines in children for relief of their symptoms and by further encouraging communication between parents and their doctors. In addition to the label change recommendations for OTC cough and cold medicines, the submission also reinforces the industry’s continued commitment to working with the FDA, Health Canada and pediatric experts to ensure that parents and doctors have appropriate treatment choices for their children through ongoing educational and scientific efforts.

Consumers , retailers or health care professionals who have questions or concerns about the products described in this communication should contact the McNeil Consumer Healthcare Contact Center at 1-800-265-7323 or visit www.tylenol.ca
McNeil Consumer Healthcare Division of McNeil PDI Inc. markets a broad range of wellknown and trusted over-the-counter (OTC) products around the globe. McNeil Consumer Healthcare in Canada markets products in the adult and pediatric pain relief, allergy, gastro-intestinal and nicotine-replacement categories under the brand names TYLENOL®, MOTRIN ®, BENYLIN®, BENADRYL® , REACTINE®, PEPCID®, IMODIUM®, ROLAIDS®, NICORETTE® and NICODERM®.