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 : 
  

  
EC23
  



  

  
Submitter : 
  

  
Ms. C. Parks
  

  
Date & Time: 
  

  
09/01/2005 04:09:08
  



  

  
Organization : 
  

  
Ms. C. Parks
  



  

  
Category : 
  

  
Individual Consumer
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 This drug should be sold over the counter, period.  If there are health risks to those younger than 16 or 17 years of age, they should be made very clear on the packaging of the drug.  There are many OTC drugs sold in dosages that are not supposed to be given to children under a certain age, but the FDA has not initiated any special sales practices in order to regulate who buys those drugs.  The same practices that are applied to other OTC drugs should be applied to this one.