McNeil Consumer Healthcare division of McNeil PDI Inc. is voluntarily withdrawing infants' cough and cold products:



    
    -  INFANTS' TYLENOL(R) COLD DYE FREE DROPS
    -  BENYLIN(R) FOR INFANTS COUGH AND COLD ORAL DROPS
    -  BENYLIN(R) FOR INFANTS STUFFY NOSE ORAL DROPS
    

    MARKHAM, ON, Oct. 11 /CNW/ - 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(R) COLD DYE
FREE DROPS, BENYLIN(R) FOR INFANTS COUGH AND COLD ORAL DROPS, AND BENYLIN(R)
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(R) Infants' Acetaminophen Drops and MOTRIN(R) 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 long-standing 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(R) COLD DYE FREE DROPS; BENYLIN(R) FOR INFANTS COUGH
AND COLD ORAL DROPS, AND BENYLIN(R) 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 well-known 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(R), MOTRIN(R), BENYLIN(R),
BENADRYL(R), REACTINE(R), PEPCID(R), IMODIUM(R), ROLAIDS(R), NICORETTE(R) and
NICODERM(R).





For further information:

For further information: For media inquiries, please contact: Shelley
Kohut, Director, Communications, Community Affairs, Philanthropy Johnson &
Johnson Inc., Tel: (514) 251-5548

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MCNEIL CONSUMER HEALTHCARE

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