Current Situation
Acetaminophen can be purchased OTC in large amounts, including bottles that contain hundreds of doses.
Options
More than one potential option exists under this general category.
• Limit the number of acetaminophen doses that can be contained in each package of OTC acetaminophen product
• Require acetaminophen tablets to be packaged in blister packs instead of bottles
• Impose restrictions on sales to limit the amount of acetaminophen that may be purchased by an individual at any one time.
Intended Effect
• To decrease the incidence of intentional ingestion of large overdoses by making it more difficult to accumulate large numbers of tablets.
• Blister packs could also help consumers track how many pills they have taken.
Considerations Related to Incidence of Hepatotoxicity (liver injury)
• Limits on amounts of OTC acetaminophen that could be purchased at one time could reduce incidence of overdose due to intentional injury.
• Limiting the availability of acetaminophen could move consumers to use other analgesics to treat pain with their attendant risk of adverse effects.
Considerations Related to Implementation
• Limiting package size could cause substantial inconvenience to consumers, particularly to those who use OTC acetaminophen routinely under a doctor’s care to treat chronic pain or arthritis.
• Blister packs could further adversely affect consumers (especially those with arthritis) because of the extra effort it takes to open blister packs.
• Manufacturer repackaging, whether in smaller container sizes, or blister packs could be costly and such costs could be passed on to consumers.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf