| Administrative law - 1993 - 438 pages
...human use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally shall, in addition to the label statement required...(tartrazine) which may cause allergic-type reactions (in§ 74.1707 eluding bronchial asthma) in certain susceptible persons. Although the overall incidence... | |
| Administrative law - 1990 - 460 pages
...human use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally shall, in addition to the label statement required...contains FD&C Yellow No. 5 (tartrazine) which may cause allergic- type reactions (including bronchial asthma) in certain susceptible persons. Although the... | |
| Administrative law - 2000 - 264 pages
...the labeling required by §201.100(d) shall bear the warning statement "This product contains PD&C Yellow No. 5 (tartrazine) which may cause allergic-type...susceptible persons. Although the overall incidence of PD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen... | |
| Administrative law - 1980 - 482 pages
...shall, in addition to the label statement required under paragraph (b)(2) of this section, bear the statement "This product contains FD&C Yellow No. 5...(including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general... | |
| Administrative law - 1993 - 440 pages
...nasally, vaginally, or rectally shall, in addition to the label statement required under paragraph (f "2i of this section, bear the warning statement "This...product contains FD&C Yellow No. 5 (tartrazine) which cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although... | |
| Steven Strauss - Medical - 2000 - 454 pages
...vagmally. The labeling for prescription drugs must have the additional statement in the package inserts: "This product contains FD&C Yellow No. 5 (tartrazine)...susceptible persons. Although the overall incidence of ... sensitivity in the general population is low, it is frequently seen in patients who also have aspirin... | |
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