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

General Information

• Medicines In My Home. An educational program about safe use of OTC medicines.
• Over-the-Counter Medicine. These materials will help you, working with your health care professionals, to choose and use over-the-counter medicine wisely.
• Over-the-Counter Medicine: All graphics and other media. These materials include brochures, pamphlets, public service announcements, and more.
• FDA Consumer Health Information
• Frequently Asked Questions on the Regulatory Process of OTC Drugs
• How FDA Regulates OTC Drugs
• New Drug Development in the U.S.
  

Specific Drug Product Information

• FDA Alert: Oral Sodium Phosphate (OSP) Products for Bowel Cleansing
  
• Public Health Advisory: Nonprescription Cough and Cold Medicine Use in Children
  
• Questions and Answers on Proposed Rule for Labeling Changes to Over-the-Counter Pain Reliever
• Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
• Safe Use of Over-the-Counter Pain Relievers (analgesics) and Fever Reducers (antipyretics)
  
• Sunscreen
  • Sunscreen Patient Information Sheet
  • Understanding SPF on Sunscreens
  • 2007 Sunscreen Proposed Rule

Press Releases

• FDA Statement Following CHPA's Announcment on Nonprescription Over-the-Counter Cough and Cold Medicines in Children
• FDA Proposes New Rule for Sunscreen Products
• FDA Informs Public of Nationwide Recall of 500mg Strength Store-Brand Acetaminophen Caplets
• FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older
• The Mentholatum Company Issues a Nationwide Voluntary Recall of WellPatch Cough & Cold Soothing Vapor Pads in the U.S.
• FDA Announces Framework for Moving Emergency Contraception Medication to Over-the-Counter Status
• FDA Warns Consumers Against Drinking High-Strength Hydrogen Peroxide for Medicinal Use
• FDA Approves a New Over-the-Counter Sunscreen Product
• FDA Warns Against Abuse of Dextromethorphan (DXM)

Contacting FDA

• Reporting adverse drug reactions and other problems with products regulated by FDA.  Even if consumers report adverse drug reactions to OTC drug manufacturers, consumers should report all adverse drug reaction to the FDA because all OTC drug manufacturers do NOT have to communicate these reports to the FDA.
• Regulations.gov. This U.S. Government web site makes it easier for you to participate in Federal rulemaking - an essential part of the American democratic process.
• Contact a public affairs specialist
• News Media Contacts
• Call the Division of Drug Information at 1-888-463-6332, or send an electronic mail message to druginfo@fda.hhs.gov
• Main FDA phone number for general inquiries, call toll-free at 1-888-463-6332.

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Date updated: December 17, 2008

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