...particular section of the FDCA states. In part, that a "drug" shall be deemed "mlsbranded" : (f) Unless Its labeling bears (1) adequate directions for use; and...pathological conditions or by children where Its use nay be dangerous to health, or against unsafe dosage or nethods or duration of administration or application,...

...adults over 18 veara of aae. Section 502 (f) of the Act provides that a drug is misbranded unless its labeling "bears (1) adequate directions for use; and...administration or application, in such manner and fora, as are necessary for the protection of users ..." (21 USC S 352(f)). Many OTC drug products are...

...adequate directions for use; and ) such adequate warnings against use in those pathological condi>ns or by children where its use may be dangerous to health, or gainst unsafe dosage or methods or duration of administration or »plication, in such manner and form,...

...drug 1s nlsbranded: *(a) If Its labeling Is false or Misleading In any particular.* •(0 Unless Its labeling bears (1) adequate directions for use; and...those pathological conditions or by children where Us use may be dangerous to health, or against unsafe dosage or methods or duration of administration...

...•gainst usi In those pathological conditions or by children where Us use My be dangerous to health, against unsafe dosage or Methods or duration of administration or application. In such Mnner and forte, as art necessary for the protection of users." Current advertising and labeling practices...

...misleading in any particular." Section 502(f) states that a drug will be misbranded . . . "unless its labeling bears (1) adequate directions for use; and...be dangerous to health or against unsafe dosage or by methods or duration of administration or application, in such manner and form, as are necessary...

...deemed to be misbranded (a) If its labeling is false or misleading in any particular. (f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use. . . . Section 201, 21 USC § 321, the "Definition" section of the Act, describes the concept of "misleading"...

...alkaloids present. Both lots of tablets were alleged to be misbranded in that the labeling did not hear adequate warnings against use in those pathological conditions or by children where their use might be dangerous to health and against unsafe dosage and duration of administration, in...