FDA Amends Labeling Requirements

What final rule requires?

The final rule requires important new organ-specific warnings and related labeling for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products.

The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using nonsteroidal antiinflammatory drugs (NSAIDs).

Final Rule Requirements

  1. Immediate Container Labeling
  2. See New Warnings Flag
  3. Liver Injury Warning For OTC Acetaminophen Products Containing Multiple Active Ingredients

DATES: Effective Date:

This final rule is effective April 29, 2010.

Compliance Date:

The compliance date for all products subject to this final rule, including products with annual sales less than $25,000, is April 29, 2010.

FOR FURTHER INFORMATION CONTACT:

Arlene Solbeck, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 209930002, 3017962090

Source: http://www.fdanews.com/ext/files/2009-28296_PI.pdf

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