If you have children under 4 years old, using over-the-counter (OTC) cough and cold medicines are no longer recommended, so you should 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, 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® (acetaminophen) and INFANTS' and CHILDREN'S MOTRIN® (ibuprofen) and also do 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

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

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

Additionally, McNeil Consumer Healthcare continues to provide education to consumers and healthcare professionals, and supports the appropriate use of children’s cough and cold medicines by initiating research and conducting enhanced safety surveillance.

McNeil Consumer Healthcare is committed to working with the FDA 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 Consumer Care Center at 1-888-222-0082 (English and Spanish).