Drug Facts Labeling Information

• OTC labeling questions and answers
  
  
• Partial delay of compliance dates
  • April 5, 2002
  • September 3, 2004 [TXT] [PDF]
    
    
• Updated labeling in Abbreviated New Drug Applications (ANDAs)  Contains Drug Facts labeling examples
   
• Exemption & deferral requests (draft guidance)
  
  
• Column Format (Drugs Facts draft guidance)
  
  
• Drug Facts related regulations
  • Final Rule
  • Drug Facts and general drug regulations
  • OTC drug monographs and OTC drug review regulations
    
    
• Docket 98N-0337: OTC Human Drugs Labeling Requirements
  
  
• Sample Drug Facts Labels

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FDA/Center for Drug Evaluation and Research
Last Updated: September 12, 2006
Originator: OTCOM/DLIS
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