Hola a todos,
Yo trabajé hace unos años para una compañia médica, y en el caso del FDA (Federal Drug Administration) existe una definición oficial. Como pueden ver, el termino labeling también incluye cualquier tipo de documentación que acompaña a un producto:
The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the FDA takes action against regulated products. Specifically:

Section 201(k) defines 'label' as a:

'display of written, printed, or graphic matter upon the immediate container of any article...'

The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper.'

Section 201(m) defines 'labeling' as:
'all labels and other written, printed, or graphic matter

(1) upon any article or any of its containers or wrappers, or

(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.