adj \ˌf-ˌlā-bəl\

Definition of OFF-LABEL

: of, relating to, or being an approved drug legally prescribed or a medical device legally used by a physician for a purpose (as the treatment of children or of a certain disease or condition) for which it has not been specifically approved (as by the United States Food and Drug Administration) <the off–label use of oral contraceptives to treat dysmenorrhea>

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