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The DailyMed database contains labeling, submitted to the Food and Drug Administration (FDA) by companies, for the following products:

• FDA-approved products:
  • Prescription drug and biological products for human use (labeling includes Prescribing Information, patient labeling, and carton and container labeling):
    • Drug products, and
    • Biological products
  • Nonprescription (e.g., over-the-counter) drug and biological products for human use
  • Certain medical devices for human use
  • Medical gases for human and animal use
  • Prescription and nonprescription drugs for animal use
• Additional products regulated, but not approved, by the FDA:
  • Certain medical devices
  • Cosmetics
  • Dietary supplements
  • Medical foods
  • Unapproved prescription and nonprescription products

The Prescribing Information (PI) for approved human prescription drug and biological products contains a summary of the essential scientific information needed for the safe and effective use of the product. The PI includes boxed warnings, indications, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug interactions, information about use in specific populations, and other important information for healthcare practitioners. FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use) is directed to the patient, family, or caregiver. FDA-approved carton and container labeling communicate information that is critical to the safe use of prescription drug and biological products from the initial prescription, to procurement, to preparation and dispensing of the drug, to the time it is given to the patient.

DailyMed

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