Drug Information

Prilosec OTC (omeprazole)

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.

• FDA Press Release
• Questions and Answers on Prilosec OTC
• Labeling
  • Trial Sample Size Labeling
  • Package Labeling
  • Blister Card Labeling
  • Configuration of Plastic Overlay for 42-Count Packages
• Prilosec OTC Approval Letter
• Prilosec Citizen Petition
• Memorandum Regarding Citizen Petition

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FDA/Center for Drug Evaluation and Research
Created: June 20, 2003
Originator: OTCOM/DLIS
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