The Food and Drug Administration told healthcare providers and customers that it agrees with the decision the drug industry took regarding the warning labels for over-the-counter cough and cold drugs.

Pediatricians and consumer advocacy groups required a ban the cold products for youngsters under 6. However, the manufacturers of cold and cough medicines announced on October 7 that they will no longer sale the over-the-counter (OTC) pediatric remedies to children under 4, and not under 6.  

"The analysis that led to the under-4 cutoff was performed by FDA," said FDA spokeswoman Rita Chappelle. "We suggested it, and then it was voluntarily adopted by industry. (They) did not come up with the proposal themselves."

According to Dr. Joshua Sharfstein, the Baltimore health commissioner who petitioned the agency to ban the use of these drugs to younger children, the OTC drugs, sold without a prescription, weren’t successful in achieving their target and could jeopardize children’s health.

The agency, which continues the process of evaluating the safety and effectiveness of children’s cough and cold drugs, held two public meetings this year: the first one in January - to recommend avoiding the use of the OTC drugs for children under 2 years of age, and the second one in October - to discuss on product labeling.

In the statement the FDA released Wednesday, the agency said no recall of over-the-counter cough and cold drugs would take place. As a consequence, there will be a period of transition in which the label of some OTC medicines will say the products shouldn’t be given to children under 2, whereas the label of others will specify “do not use” for children under 4 years of age.