A special warning could be included for parents of infants two to four months old to have a physician check for a more serious condition before administering the drug. The committee discussed labeling directions for both suspension liquids and double concentrated infant drops. Both formulations exist for products including Children's Tylenol, Children's Motrin, and Children's Advil. FDA has shown increasing interest in pediatric drug labeling. It has issued a proposed rule requiring testing of some prescription drugs for safety when used by children, as well as appropriate dosages and labeling.
FDA's Nonprescription Drugs Advisory Committee has recommended that labels of OTC pediatric analgesic and antipyretic drugs could contain directions for children down to two months of age.
Oct 31st, 1997