http://discovermagazine.com/2008/jan/fda-says-cold-medicine-is-not-for-children-under-6

18. FDA Says Cold Medicine is Not For Children Under 6
by Apoorva Mandavilli

In October, Food and Drug Administration (FDA) advisers recommended against the use of most nonprescription cold and cough medicines for children under age 6, citing

the lack of evidence of safety or efficacy

in this age group. Prior to the announcement, most manufacturers had already voluntarily restricted sales of medicines formulated for children less than 2 years old.

The FDA review of the medications began after a report by the Centers for Disease Control in January found that, between 2004 and 2005, more than 1,500 children under the age of 2 had wound up in emergency rooms after taking over-the-counter cough and cold medicines. In another development that prompted the review, Baltimore city officials filed a citizen petition with the FDA in March, noting that the remedies do not help children under 6 years of age and may in fact harm them.

There are roughly 800 -products on the market containing antihistamines, decongestants, anticough agents, and other chemicals intended to treat colds and coughs in children. Like many pediatric medicines, they have been tested only in adults and are simply packaged to deliver smaller doses to children.