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 : EC751
Submitter : Mr. Matthew Lipscomb Date & Time: 10/13/2005 08:10:00
Organization : Mr. Matthew Lipscomb
Category : Health Care Association
Issue Areas/Comments
GENERAL
GENERAL
This drug is entirely to dangerous to be 'over the counter' NO MATTER the age. You likened this drug to other OTC drugs like cough syrup. When was the last time cough syrup coused the problems and side effects this has caused?

When was the last time cough syrup caused the mental trauma and anguish this pill can cause?

Please help protect women from the money hungry grug companies who do not have women's health as their top priority in this case. This is all about profit!!

It saddens me to think my daughters could buy this drug JUST AS EASILY as they can buy Advil.

Please don't do this.

Matt