Over-the-Counter (OTC) Dosage Delivery Devices
On May 4, 2011, the U.S. Food and Drug Administration (FDA) issued a final guidance for industry with the Agency's recommendations for improving dosage delivery devices, such as cups and droppers, for over-the-counter (OTC) (i.e., non-prescription) orally ingested liquid drug products. The intent of this guidance is to suggest ways manufacturers can improve their labeling in order to minimize the risk of accidental overdose.
- Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (PDF - 595KB)
Questions and Answers on Guidance for Industry: Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products Ten Tips to Prevent an Accidental Overdose
- Press Release: FDA issues final guidance for liquid OTC drug products with dispensing devices [ARCHIVED]