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GUIDANCE DOCUMENT

Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products September 2022

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2021-D-0528
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2021-D-0528.

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