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• The FDA 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.

  FDA - Cite This Source - This Definition
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  Cite Definition for label

  American Psychological Association (APA)

  label. (n.d.). [email protected] Glossary of Terms. Retrieved June 6, 2023, from website: http://www.expertglossary.com/definition/label.

  Chicago Manual of Style (CMS)

  label. www.fda.gov. [email protected] Glossary of Terms. FDA. http://www.expertglossary.com/definition/label (accessed: June 6, 2023).

  Modern Language Association (MLA)

  "label." [email protected] Glossary of Terms. FDA. 6 June. 2023 http://www.expertglossary.com/definition/label.

• Browse Related Terms: Approval History, Discontinued Drug Product, FDA Action Date, label, Marketing Status, Reference Listed Drug (RLD), Route, Supplement, Supplement Number, Supplement Type, Tentative Approval

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