FDA may establish Acetaminophen Package limits for OTC Products

Current Situation

Acetaminophen can be purchased OTC in large amounts, including bottles that contain hundreds of doses.



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.


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