FDA limits packaging for loperamide to encourage safe use

To help address abuse and misuse, the FDA approved changes to the packaging for tablet and capsule forms of the over-the-counter antidiarrheal drug.


The FDA has approved changes to the packaging for tablet and capsule forms of loperamide to address abuse and misuse of the over-the-counter (OTC) antidiarrheal drug, the agency announced on Sept. 20.

The packaging changes will affect the following brand-name OTC medications: Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules. The changes limit each carton to no more than 48 mg of loperamide and require the tablets and capsules to be packaged in individual doses.

The FDA said it will continue to work with manufacturers of OTC loperamide, including those of generic and liquid products, to institute appropriate package sizes and types that support safe use.