...shall be established by regulations promulgated by the Secretary. (f) Unless its labeling bears (I) adequate directions for use: and (2; such adequate...use in those pathological conditions or by children whore its use may be dangerous to health, or against unsafe dosage or methods or duration of administration...

...form as may be prescribed by regulations, a* provided by sections 701 and 703, against use in such pathological conditions or by children where its use may be dangerous to health, or against untafe dosage or methods or duration of administration of application. The provision is unnecessary...

...disclosed to tbe Secretary. it) Unless Its labeling bears (1) adequate directions for use; and (2) such warnings against use In those pathological conditions or by children where Its use may be dsngerous to health, or •gainst unsafe dosage or methods or duration of administration or application....

...might result from Its use under the conditions of use prescribed In the labeling and failed to bear warnings against use In those pathological conditions, or by children where Its use might be dangerous to health, or against unsafe dosage, or methods or duration of administration In...

...amendment a drug or device Is considered misbranded unless Its labeling bears such warnings against use in pathological conditions or by children where Its use may be dangerous to health cr against unsafe dosage or methods or duralion of administration or application. In such manner and...

...Pierided, That the reqitirosentfor .¿atiag tAe guais1¿y 36 DRUG AM$NDMZN'rs 01' 191$ (f) Unless its labeling bears (1) adequate directions for. use and (2) such adequate warnings a¿ainat use in those pathological conditions or by children where ite use may be dangerous to health,...

...and Unless its label bears (1) adequate directions for use, and (2) such adequate warnings against. . .where Its use may be dangerous to health, or against unsafe dosage or met.ods or duration of administration or application, in such manner and form, as are necessary for...

...be mlsbranded (a) If its labeling is false or misleading in any particular, and (f) Unless its label bears (1) adequate directions for use, and (2) such adequate warnings against. ..where Its use may be dangerous to health, or against unsafe dosage or meti.ods or duration of administration...

...active ingredient, including the quantity, kind, and proportion or any alcohol. . . . (f) Unless its labeling bears (1) adequate directions for use; and...pathological conditions or by children where its use may dangerous to health, or against unsafe dosage or methods or duration of administration or application...

...USC 352] ******* (f) Unless its labeling bears (1) adequate directions for use; and (2) such adequs" warnings against use in those pathological conditions...or against unsafe dosage or methods or duration of administn; tion or application, in such manner and form, as are necessary for the protection o! users,...