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# Dosage and Administration Label Section Guidance
- URL: https://www.fdaweb.com/dosage-and-administration-label-section-guidance/
- Published: 2023-01-12T12:00:00.000Z
- Updated: 2026-09-14T18:11:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153525

FDA has published a guidance, *Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format*, to help ensure that applicants include in the Dosage and Administration section of proposed labeling all the information needed for safe and effective dosing and administration of a drug and that the information is clear and accurate. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-and-format-dosage-and-administration-section-labeling-human-prescription-drug-and-biological?ref=fdaweb.com) has recommendations on:

- the types of information that should be included;
- a format for organizing that information within the section; and
- when to include information from other labeling sections in the Dosage and Administration section and how to present that information.