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FDA: Dosage Delivery Devices for OTC Liquid Drug Products

09.11.2009
This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing over-the-counter (OTC) liquid drug products (e.g., elixirs, suspensions, solutions, syrups) that are packaged with dosage delivery devices (e.g., calibrated cups, droppers, syringes, spoons).2 Because written, printed, or graphic matter appearing on dosage delivery devices packaged with OTC liquid drug products is considered labeling, such markings on these devices must not be false or misleading and must be clear and consistent with the drug product’s directions for use.