In January 2008, manufacturers voluntarily removed over-the-counter (OTC) infant (less than 2 years of age) cough and cold products from the market due to safety concerns. Later in fall of 2008, manufacturers also voluntarily relabeled these cough and cold products to state: “do not use in children under 4 years of age.” However, there are concerns that many parents may be giving cough and cold products that remain on the market - those designed for older children - to their infants. FDA reminds all caregivers never to give a child under two years of age any kind of cough and cold p...

The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.

The FDA is warning parents, caregivers and health care providers not to feed SimplyThick , a thickening agent for management of swallowing disorders, to infants born before 37 weeks.

FDA notified healthcare professionals that the Pregnancy section of drug labels for the entire class of antipsychotic drugs has been updated.