Important Information About OTC Pediatric Medicines from McNeil Consumer Healthcare

Dear Healthcare Professional:

At McNeil Consumer Healthcare, we are committed to the health and safety of your patients. As part of this commitment, we would like to share important information related to over-the-counter (OTC) pediatric cough and cold medicines. As part of the industry's continuing dialogue with the Food and Drug Administration (FDA), McNeil Consumer Healthcare 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 and other manufacturers, McNeil Consumer Healthcare 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, the 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)

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 relievers/fever reducers such as INFANTS' and CHILDREN'S TYLENOL® (acetaminophen) and INFANTS' and CHILDREN'S MOTRIN® (ibuprofen) and also does not apply to single-ingredient allergy medicines such as CHILDREN'S ZYRTEC® (cetirizine) and CHILDREN'S BENADRYL® (diphenhydramine).

The following cough and cold medicines should no longer be used in children under age 4 years:

Children's TYLENOL® Plus Multi-Symptom Cold
Children's TYLENOL® Plus Cold
Children's TYLENOL® Plus Cough & Sore Throat
Children's TYLENOL® Plus Cough & Runny Nose
Children's TYLENOL® Plus Flu
Children's TYLENOL® Plus Cold & Allergy
Children's SUDAFED® Nasal Decongestant
Children's SUDAFED® PE Nasal Decongestant
Children's SUDAFED® PE Cold & Cough
PEDIACARE® Multi-Symptom Cold
PEDIACARE® Long-Acting Cough
PEDIACARE® Decongestant
PEDIACARE® NightRest Multi-Symptom Cold
PEDIACARE® NightTime Cough
Children's BENADRYL®-D Allergy & Sinus

The following children's medicines that contain an antihistamine will be re-labeled to feature a new warning; "do not use to make a child sleepy":

Children's BENADRYL® Allergy Liquid
Children's BENADRYL® Allergy Dye-Free Liquid
Children's BENADRYL® Allergy Perfect Measure
Children's BENADRYL®-D Allergy & Sinus
Children's TYLENOL® Plus Multi-Symptom Cold
Children's TYLENOL® Plus Cold
Children's TYLENOL® Plus Cough & Runny Nose
Children's TYLENOL® Plus Flu
Children's TYLENOL® Plus Cold & Allergy

Along with this action, we continue to support a national educational campaign that will build awareness for parents and caregivers about how to appropriately use these medicines.

We ask that you share this important information with parents and caregivers and recognize that your patients will likely have many questions. To help answer some of these questions, we will continue our long-standing commitment of educating parents and caregivers about the appropriate use of over-the-counter medicines, with a specific focus on pediatric cough and cold medicines. For this educational effort to have the greatest effect, we are seeking your help and commitment.

You can help facilitate the appropriate use of OTC pediatric cough and cold medicines by encouraging parents and caregivers to:

Read and follow the labeled instructions on OTC medicines
Use the dosing device that comes with a specific product
Keep all medicines out of the reach of children
Not administer two products containing the same active ingredients
Not administer adult medicines to children
Not use cough and cold or allergy medicines to sedate children

McNeil Consumer Healthcare is committed to working with the FDA to continue to provide parents and caregivers with appropriate treatment choices for children. To help support you in educating parents and caregivers, you can turn to this Web site (Tylenolprofessional.com) for additional information. This site should serve as a continuing resource to help you and your staff in this education.

Thank you for your continued trust and support. If you have any questions please do not hesitate to call us at 1-888-222-0082.

Sincerely,

Edwin K. Kuffner, MD
Senior Director, Medical Affairs
McNeil Consumer Healthcare