If you have children under the age of 6 years, do not use OTC cough cold medicines in such children. Talk to your doctor about other ways to treat your child’s cold. Single-ingredient pain relievers and fever reducers such as Infants’ and Children’s TYLENOL* are still recommended.
As with other OTC labeling changes in the past, Health Canada has indicated it does not believe this labeling change warrants the removal of products with the old labeling from store shelves during this time of transition. The transition of re-labeled McNeil Consumer Healthcare medicines should be complete by Fall of 2009. (Please see a complete list of affected McNeil Consumer Healthcare medicines below)
“Over-the-counter pediatric cough and cold medicines have helped families provide comfort for their children for more than 30 years,” said Bill Murphy, Vice President OTC, Latin America and Canada McNeil Consumer Healthcare. “McNeil Consumer Healthcare has always encouraged the appropriate use of these medicines. Our actions today include label changes, educational initiatives for parents, caregivers and healthcare professionals as well as science and surveillance commitments.”
McNeil Consumer Healthcare’s pediatric cough and cold medicines will continue to include dosing information for children age 6 years and older. The label changes do not apply to single-ingredient pain reliever/fever reducers such as Infants’ and Children’s TYLENOL* (acetaminophen) and Infants’ and Children’s MOTRIN® (ibuprofen).
The following cough and cold medicines should no longer be used in children under age 6 years:
Children’s TYLENOL*
Children's TYLENOL* Cold
Children's TYLENOL* Cold & Cough
Children's TYLENOL* Cold & Cough Nighttime
Children's TYLENOL* Cough & Runny Nose
Children's TYLENOL* Decongestant
Children's TYLENOL* Cold & Cough (Cold DM)
Junior Strength TYLENOL* Cold & Cough (Cold DM)
McNeil Consumer Healthcare is committed to working with Health Canada to continue to provide parents and caregivers with appropriate treatment choices for children.
For More Information
Consumers or retailers who have questions or concerns about the medicines described in this communication should contact the Information Centre at 1-800-265-7323.
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