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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:

  • Contains a summary of the essential scientific information needed for the safe and effective use of the drug; and
  • Includes the Prescribing Information, FDA-approved patient labeling (Medication Guides, Patient Package Inserts, and/or Instructions for Use), and/or carton and container labeling.

For assistance on how to navigate this webpage and the associated FDA labeling resource webpages for human prescription drugs see video.

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

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