NMA: Nonprescription Medicines Academy

Changes Ahead for Nonprescription Analgesics

July 9th, 2009

The FDA has issued a final rule that affects the labeling of all nonprescription analgesics now and recommendations that may affect acetaminophen in the future.

On June 29 and 30, 2009, three FDA advisory committees met to consider a series of options for further reducing the incidence of liver injury associated with acetaminophen use that exceeds the maximum recommended dose (4 g/day). These options included:

  • Reducing the amount of acetaminophen recommended as a daily dose.
  • Limiting the amount of acetaminophen in nonprescription products to 325 mg per tablet (650 mg recommended dose).
  • Establishing package size limits for nonprescription acetaminophen products.
  • Eliminating combination products that contain acetaminophen.
  • Standardizing the concentration of liquid acetaminophen products.
  • These options did not include recommending an elimination of OTC combination products or smaller package size.

Patients with questions about prescription or nonprescription analgesics can access the FDA Consumer Health Information Update titled “A Guide to Safe Use of Pain Medicine” at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095673.htm.

Author: Cynthia Knapp Dlugosz, BPharm
Date: June, 2009