Updated Information about Children’s Cough and Cold Medicines.

If you have children under 4 years old, using over-the-counter(OTC) cough and cold medicines is no longer recommended, so you should talk to your doctor about other ways to treat your child's cold.

For children age 4 and over, OTC  medicines  including PEDIACARE®  cough and cold products remain safe and effective when used as directed. Because reports of adverse events are very rare, and mostly associated with misuse or accidental ingestion in children under age 2, the FDA supports the continued use of these medicines for symptom relief in children age 4 and older.

McNeil Consumer Healthcare's (the makers of PEDIACARE®) pediatric cough and cold medicines will continue to include dosing information for children under age of 4 years and older.

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."

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 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.

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

PEDIACARE® Decongestant

PEDIACARE® Multi-Symptom Cold

PEDIACARE® Long-Acting Cough

PEDIACARE® NightRest Multi-Symptom Cold

PEDIACARE® NightTime Cough

The following PEDIACARE® products that contain an antihistamine should not be used to make a child sleepy:

PEDIACARE® NightRest Multi-Symptom Cold

PEDIACARE® NightTime Cough

"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 is committed to working with the FDA to continue to provide parents and caregivers with appropriate treatment choices for children .

For More Information

Contact the PEDIACARE®  Consumer Care Center at 1-888-222-0082.