...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented; and (ii) If the article is subject to section 505,...

...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented; and (2) If the article is subject to section 505,...

...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...administer the drug can use the drug safely and for the pur§201.100 poses for which it is intended, including all purposes for which it is advertised or represented;...

...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...administer the drug can use the drug safely and for trie purposes for which it is intended, including all purposes for which it is advertised or represented;...

...for its use, including indications, effects, dosages, routes, methods, and frequency §1.106 §1.106 and duration of administration, and any relevant hazards,...the purposes for which it is intended, including all purposes for which it is advertised or represented; and <ii) If the article is subject to section 505,...

...also be insufficient if: (1) The specimen labeling proposed fails to bear adequate information for use, including indications, effects, dosages, routes,...licensed by law to administer the drug can use the drug for the purposes for which it is intended, including all purposes for which it is to be advertised,...

...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented ; and, if the article is subject to section 505,...

...on or within the package from which the drug is to be dispensed bears adequate Information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented ; and "If the article is subject to (the new drug,...

...on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes,...the purposes for which it is intended, including all purposes for which it is advertised or represented. . . ." The package insert originates as a part...

...condition requires that any labeling of a prescription drug shall contain adequate information for use including indications, effects, dosages, routes,...administer the drug can use the drug safely and for the purpose for which it is intended and, if the drug is subject to 21 USC 355, the labeling providing...