FDA issued the warning Wednesday as a part of broad reassessment of the safety of some popular medicines that had caused adverse reactions and deaths in children less than 2 years old.
Cough and cold medicines contain dextromethorphan and pseudoephedrine that can cause neurological problems, like abnormal movements and hallucinations, even when a child is given in standard doses.
Pseudoephedrine, a decongestant has long been associated with infant deaths, increased blood pressure and arrhythmias.
As of now, the labels on infant and children's formulas of cold medications advise parents to see a doctor before giving the medicines if their child is under the age of two.
Parents should carefully follow directions for use that come with a medication, the FDA said adding that parents should not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called "pediatric" use).
FDA launched an investigation warning after one group petitioned the federal agency to issue a market ban on sale of the drugs for children under the age of 6.
Additionally, a group of doctors also petitioned the agency in March to review the situation and public health authorities raised concerns about the products.
On October 18, the federal agency will ask a panel of experts if warnings should affect the sales of the medications.
