Cold and Cough Medicines: Information for Parents

It's winter, and parents may be tempted to reach for over-the-counter medicines to ease their child's sniffling and coughs. But recent safety concerns have prompted drug manufacturers to change their labels stating that cough and cold medicines should NOT be given to children younger than age 4. Parents can take some steps now to help keep their children safe.

Each year, thousands of children under age 12 go to emergency rooms after taking over-the-counter cough and cold medicines. Most of these children were unsupervised when they took the medicine.

In response to safety concerns, the leading manufacturers of children's cough and cold medicines are voluntarily changing the labels on these products to state that they should not be used in children younger than 4 years of age.

Previously, the labels stated that these medicines should not be given to children under age 2. Products with the old labels will not be removed immediately from store shelves but are expected to gradually be replaced with products bearing the new labels. Doctors and nurses should be aware of the new labels and alert parents and caregivers about this important change.

Parents can help protect their children by doing the following:

Do

• Throw away old cold and cough medicines labeled for children less than age 4.
• Read the label carefully to see what ingredients are in any medicine you give your child. 

Don't

• Don't leave any medicines where your child might be able to reach them.
• Don't tell children that medicine is candy.
• Don't take adult medicines in front of your child.
• Don't give children younger than age 4 any medicines intended for older children.
• Don't give your child two medicines that contain the same ingredients.

For tips on safely managing coughs and colds, talk to your child's doctor or your pharmacist.

More Information

• Revised Product Labels for Pediatric Over-the-Counter Cough and Cold Medicines. Centers for Disease Control and Prevention. MMWR 2008;57:1180.
• FDA Statement Following CHPA's Announcement on Nonprescription Over-the-Counter Cough and Cold Medicines in Children
• Statement from Consumer Healthcare Products Association on the Voluntary Label Updates to Oral OTC Children's Cough and Cold: Medicines
• Tips to Prevent Poisonings, National Center for Injury Prevention and Control
• Schaefer MK, Shehab N, Cohen AL, Budnitz DS. Adverse Events Attributable to Cough and Cold Medications in Children.* Pediatrics. Epub 28 Jan 2008. DOI: 10.1542/peds.2007-3638.