The FDA approved new packages for OTC branded forms of the anti-diarrhea drug loperamide, limiting each carton to no more than 48 milligrams and requiring unit-dose blister packaging.
Some opioid abusers take the drug in high doses for treatment of withdrawal symptoms. In 2017, the FDA added a warning to the product’s Drug Facts panel on the risk of serious heart problems or death from using high doses.
The new packaging is for Imodium A-D, Imodium Multi-Symptom Relief and Be Health Loperamide HCl Capsules. The maximum approved dose of OTC loperamide for adults is eight milligrams per day and 16 milligrams per day for prescription use.