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  6. Frequently Asked Questions about Labeling for Prescription Medicines
  1. FDA’s Labeling Resources for Human Prescription Drugs

Frequently Asked Questions about Labeling for Prescription Medicines

For Healthcare Professionals

Frequently asked questions about labeling for prescription drugs (medicines) on this webpage are primarily directed to healthcare professionals (for example, doctors, nurse practitioners, physician assistants, pharmacists, nurses).  For information about prescription drug labeling resources primarily directed to industry such as those for the Prescribing Information, FDA-approved patient labeling, carton and container labeling, biological product labeling, generic drug labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Prescription Drugs.

Labeling for prescription medicines is FDA’s primary tool for communicating drug information to healthcare professionals, and patients and their caregivers.  Labeling for prescription medicines includes:

  • Prescribing Information (labeling for healthcare professionals),
  • Carton and container labeling (cartons and containers are outside packaging that contain information about prescription medicines), and
  • Labeling for patients or caregivers (e.g., Medication Guides, Patient Package Inserts, and Instructions for Use). 

Labeling for prescription medicines is required for all FDA-approved prescription medicines. Such labeling is:

  • Proposed by the drug company,
  • Reviewed by the FDA, and
  • If acceptable, approved by the FDA. If the labeling for a new medicine is found to be unacceptable by the FDA, the medicine will not be approved by the FDA.

All prescription medicines have Prescribing Information and carton and/or container labeling and many, but not all, have labeling for patients or caregivers. For additional background about labeling for prescription medicines see:

Contact Information

For specific application or supplement questions or for general questions about prescription drug labeling, please visit Prescription Drug Labeling Contact Information.

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