GUIDANCE DOCUMENT
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products September 2022
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2021-D-0528
- Docket Number:
- FDA-2021-D-0528
- Issued by:
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Guidance Issuing OfficeCenter 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.