OTC Pediatric Acetaminophen Guidance More Flexible By Omission

The guidance largely tracks a 2014 draft guidance but omits statements on discouraging use of droppers as dosing devices and changes some language to clarify where firms have some leeway in stating label information.

FDA guidance on pediatric OTC oral liquid acetaminophen products provides more flexibility than the draft, notably by striking a recommendation against using droppers as dosing devices and rephrasing other statements to clarify a firm’s options.

The guidance omits a statement made in the October 2014

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