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  1. Development & Approval Process (Drugs)

Drugs@FDA: What's in a Drug Product Label?

Drugs@FDA: What's in a Drug Product Label?

Information in Drug Product Labels

 
  • description of the drug
  • clinical pharmacology
  • indications (uses for the drug)
  • contraindications (who should not take the drug)
  • warnings
  • precautions
  • adverse events (side effect)
  • drug abuse and dependence
  • dosage and administration
  • use in pregnancy, use in nursing mothers
  • use in children and older patients
  • how the drug is supplied
  • safety Information for the patient