The leading makers of over-the-counter (OTC) oral pediatric cough and cold medicines want to reassure consumers that children's over-the-counter medicines are safe and effective when used according to label instructions. While the vast majority of parents and caregivers safely use the medicines to help relieve their children’s symptoms, rare cases of incorrect dosing or accidental ingestion in very young children have occurred.

Here is the background:
On October 2, 2008, FDA convened an open public meeting to gather more information on the regulatory process for pediatric cough and cold medicines and on the issue of scientific testing in children. FDA has said that adverse events associated with pediatric cough and cold medicines are rare, but the science-based agency also recognizes that there are limited medical trials available upon which to make an ultimate determination about any changes to the monograph. The October meeting was intended to help provide the FDA with more data specific to pediatric populations to confirm the correct dosing and safe use of these products. CHPA and its members participated in the meeting.

Although problems with these medicines are very rare and mostly related to incorrect dosing and curious, young children getting into medicines, manufacturers are voluntarily changing labels for children under age 4. Medicine makers have begun transitioning new labels onto store shelves based on consultations with the U.S. Food and Drug Administration. Adult cough and cold medicines are not included in this process.

The safe use of these medicines is the highest priority.

The safe use of these medicines is the highest priority. Medicine makers will continue their long history of providing consumer education with the launch of a new, multi-year national educational program to build awareness among parents and other caregivers and healthcare professionals about how to safely use OTC cough and cold medicines in children, and, as importantly, when not to use them.

Parents and caregivers should use the following tips for safe and effective dosing in children:

Always following dosing directions exactly, and use the measuring device that comes with the medicines.

• Always read and follow medicine labels exactly and use the measuring device that comes with the medicine.
• Do not give a medicine only intended for adults to a child.
• Only give the medicine that treats your child’s specific symptoms.
• Never give two medicines at the same time that contain the same active ingredient.
• Do not use oral cough and cold medicines for children under age 4.
• Never use an OTC medicine to sedate or make a child sleepy.
• Never give aspirin-containing products to a child for cold or flu symptoms unless told to do so by a doctor.
• If your child develops any side effects or reactions that concern you, stop giving the OTC medicine and contact a doctor immediately. 
• Keep all medicines out of your child’s reach and sight.
• Talk to a doctor, pharmacist, or other healthcare provider if you have any questions.

The over-the-counter medicine industry’s consumer education foundation has more tips at OTCsafety.org for safely giving medicines to children.