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                Center for Drug Evaluation and Research | CDER

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          Prilosec OTC (omeprazole) InformationCenter for Drug Evaluation and Research | CDER Prilosec OTC (omeprazole) Information
  
  	
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    PrintThe Food and Drug Administration (FDA) has approved Prilosec OTC (omeprazole), the first over-the-counter treatment for frequent heartburn.  Prilosec OTC is a delayed-release 20 mg tablet that must be taken before eating once a day, every day for 14 days.  Prilosec OTC may take one to four days for full effect, although some consumers may get complete relief of symptoms within 24 hours.Questions and Answers on Prilosec OTCLabeling Trial Sample Size labeling (PDF - 1 MB)Package labeling (PDF - 217 KB)Blister Card Labeling (PDF - 187 KB)Configuration of Plastic Overlay for 42-Count Packages (PDF - 390 KB)Prilosec OTC Approval Letter (PDF -119 KB)Prilosec Citizen Petition (PDF - 1.9 MB)Memorandum Regarding Citizen Petition (PDF - 40 KB)Related InformationProton Pump Inhibitors InformationConsumer Information: Safe Use of Over-the-Counter Drug Products

                                                                                  Content current as of:
      11/27/2015Center for Drug Evaluation and Research | CDER

          
                        CDER Offices and Divisions
          Meeting Presentations | Drugs
          CDER Exclusivity Board


                        Accelerating Rare disease Cures (ARC) Program
          CDER Contact Information
          CDER Manual of Policies & Procedures | MAPP
          Frequently Asked Questions about CDER
          Reports & Budgets | CDER
 
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