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According to U.S. Code 321(m), the term "labeling" means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers or (2) accompanying such an article.

For most purposes, prescription drug labeling refers to the printed information that accompanies prescription drugs (that is, the folded paper inside the carton). The primary purpose of prescription drug labels is to give health care professionals the information they need to prescribe drugs appropriately.