Drug Information Update - FDA Releases Drug Dosage Guidance for Measuring Devices Included with OTC Medications

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Title: Drug Information Update - FDA Releases Drug Dosage Guidance for Measuring Devices Included with OTC Medications

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


The Food and Drug Administration (FDA) made public a new guidance for companies that manufacture, market, or distribute over-the-counter liquid medications packaged with dosage delivery devices such as calibrated cups, droppers, syringes and spoons. The guidance document, titled “Dosage Delivery Devices for OTC Liquid Drug Products,” was posted for advanced viewing in the Federal Register today.

Accidental overdoses can be caused by dosage delivery devices that are unclear or are inconsistent with the labeled dosing instructions.

"This new drug dosage guidance document is an example of steps that can be taken to ensure safer medication use,” said Woodcock. “Many accidental overdoses result from confusion about exactly how much of a drug to take. Better measuring devices will help patients, parents, and other caregivers use the right amount of these medications – the safest and most effective dose – especially for children.”

The draft guidance is available at: Dosage Delivery Devices


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