Prilosec OTC (omeprazole) Information

The 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 OTC
• Labeling
  • 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 Information

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• Consumer Information: Safe Use of Over-the-Counter Drug Products