2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC957
Submitter : Mr. Bruce Van Nostrand Date & Time: 10/27/2005 08:10:51
Organization : Mr. Bruce Van Nostrand
Category : Individual Consumer
Issue Areas/Comments
Children, especially those under the age of 18, should not have access to this drug in any form, let alone as an OTC drug