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Medical Term:

package insert

 

Definition: printed materials available in the legal pharmacologic description of a drug, subject to detailed regulatory specifications, including approved chemical and proprietary names, description and classification, clinical pharmacology, approved indications and usage, contraindications, warnings, precautions, adverse reactions, drug abuse and dependence information, overdosage discussion, dosage and administration, formulations, and appropriate references; in the U.S., such materials are negotiated between the drug's manufacturer(s) and the U.S. Food and Drug Administration.

See Also: label3

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