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Loperamide child-proof packaging

Executive Summary

Regulation to require child-resistant closures on antidiarrheal products containing 0.045 mg loperamide proposed by Consumer Product Safety Commission in Oct. 14 Federal Register notice. The reg would apply to vials of prescription capsules and OTC caplet and liquid forms. McNeil currently markets OTC Imodium A-D in child-resistant containers. However, CPSC noted that "other products may come on the market." Loperamide is structurally related to the opium alkyloids. The medical literature includes reports of 11 deaths of children under five due to loperamide poisoning, although most incidents involve "intentional administration of loperamide to children" in foreign countries, CPSC states. The reg will take effect 30 days after a final reg is published because currently marketed loperamide products already include child-resistant packaging, CPSC said. Comments are due by Dec. 28.

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