Issue Date: September 8, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Draft
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products
This guidance provides recommendations for quantitative labeling of sodium, potassium, and phosphorus present in human prescription and nonprescription (commonly referred to as over-the-counter (OTC)) drugs. This guidance addresses sodium, potassium, and phosphorus when present as constituents of active or inactive drug ingredients (e.g., sodium as a constituent of the inactive ingredient anhydrous trisodium citrate, phosphorus as a constituent of the inactive ingredient dibasic calcium phosphate, or sodium as a constituent of the active ingredient naproxen sodium). Products within the scope of this guidance’s recommendations are orally ingested products and injectable medications containing an amount of 5 mg or more of sodium, potassium, or elemental phosphorus per maximum single dose. Individuals or entities responsible for drug product labeling are encouraged to engage with FDA for advice on specific cases.
Download the Guidance Document
