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FDA’s Labeling Resources for Human Prescription Drugs

For Industry

FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug* labeling. Human prescription drug labeling (1) contains a summary of the essential scientific information needed for the safe and effective use of the drug; and (2) includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or carton and container labeling.

If you are a healthcare professional, patient, or caregiver, visit Frequently Asked Questions about Labeling for Prescription Medicines.

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For specific application or supplement questions or for general questions about prescription drug labeling

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