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# New Packaging OK’d to Reduce Loperamide Abuse
- URL: https://www.fdaweb.com/new-packaging-okd-to-reduce-loperamide-abuse/
- Published: 2019-09-20T12:00:00.000Z
- Updated: 2026-09-15T01:51:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145057

FDA has approved package size and package type limits for over-the-counter (OTC) forms of loperamide, indicated for controlling symptoms of diarrhea. The changes are intended to address the problem of loperamide abuse and misuse ([see earlier story](https://www.fdaweb.com/continued-heart-safety-issues-seen-with-imodium-fda/)) by limiting each carton to no more than 48 mg of loperamide and requiring unit-dose blister packaging. “The maximum approved daily dose of OTC loperamide for adults is 8 milligrams per day and 16 milligrams per day for prescription use,” [FDA says](http://s2027422842.t.en25.com/e/es?s=2027422842&e=256098&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=36115fe3b8bc4c32b8707a23e2b5699a&elqaid=9566&elqat=1&ref=fdaweb.com). “While loperamide is safe at approved doses, the FDA has received reports of serious heart problems and deaths associated with loperamide, and the majority of reported serious heart problems occurred in individuals who were intentionally misusing and abusing high doses of loperamide.” A heart alert warning was added to loperamide’s Drug Facts label in 2017.