label
- Guideline or reference source
- FDA www.fda.gov
- Definition
- The approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.
- Used For
- package insert
- Broader Term
- labelling
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