FORT WASHINGTON, Pa., Oct. 7 /PRNewswire/ -- As part of the industry's
continuing dialogue with the U.S. Food and Drug Administration (FDA), McNeil
Consumer Healthcare, a division of McNeil-PPC, Inc., announced today new
voluntary actions that will help further encourage safe and appropriate use of
children's cough and cold medicines.
After consulting with the FDA, McNeil Consumer Healthcare and other
manufacturers will transition the labeling on children's cough and cold
medicines to state 'do not use' in children under age 4 years; and the labels
on children's medicines containing a monograph antihistamine will also feature
a warning, 'do not use to make a child sleepy.' Pediatric cough and cold
medicines remain safe and effective when used as directed; and because reports
of adverse events are very rare, and mostly associated with misuse or
accidental ingestion in younger children, the FDA supports the continued use
of these medicines for symptom relief in children age 4 years and older.
As with other OTC labeling changes in the past, FDA 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 before the
end of the year. (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 Ashley
McEvoy, President, 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 4 years and older.
The label changes do not apply to single-ingredient pain reliever/fever
reducers such as INFANTS' and CHILDREN'S TYLENOL(R) (acetaminophen) and
INFANTS' and CHILDREN'S MOTRIN(R) (ibuprofen) and also do not apply to single-
ingredient allergy medicines such as CHILDREN'S ZYRTEC(R) (cetirizine) and
CHILDREN'S BENADRYL(R) (diphenhydramine).
The following cough and cold medicines should no longer be used in
children under age 4 years:
1. Children's TYLENOL(R) Plus Multi-Symptom Cold
2. Children's TYLENOL(R) Plus Cold
3. Children's TYLENOL(R) Plus Cough & Sore Throat
4. Children's TYLENOL(R) Plus Cough & Runny Nose
5. Children's TYLENOL(R) Plus Flu
6. Children's TYLENOL(R) Plus Cold & Allergy
7.
