 | Administrative law - 1997 - 200 pages
...vaginally, or rectally, or for use in the area of the eye, the labeling required by §201.100(d) shall bear the warning statement "This product contains...appear in the "Precautions" section of the labeling. (c) The label for over-the-counter drug products intended for human use administered orally, nasally,... | |
 | Administrative law - 1990 - 198 pages
...use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally shall bear the warning statement "This product contains...appear in the "Precautions" section of the labeling. (c) The label for over-the-counter drug products intended for human use administered orally, nasally,... | |
 | Administrative law - 1994 - 196 pages
...or rectally shall bear the warning statement "This product contains FD&C Yellow No. 6 (tartrazlne) which may cause allergictype reactions (including...appear in the "Precautions" section of the labeling. (c) The label for over-the-counter drug products intended for human use administered orally, nasally,... | |
 | Administrative law - 2000 - 264 pages
...(including bronchial asthma) in certain susceptible persons. Although the overall incidence of PD&C Yellow No. 5 (tartrazine) sensitivity in the general...appear in the "Precautions" section of the labeling. (c) The label for over-the-counter drug products intended for human use administered orally, nasally,... | |
 | Administrative law - 1989 - 240 pages
...(tartrazine) sensitivity in the general population is low, it is frequently seen in pa§201.22 tients who also have aspirin hypersensitivity." This warning...appear in the "Precautions" section of the labeling. (c) The label for over-the-counter drug products intended for human use administered orally, nasally,... | |
 | Administrative law - 1980 - 482 pages
...may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No....patients who also have aspirin hypersensitivity." This statement shall appear in the "Precautions" section of the labeling. (d) Certification. All batches... | |
 | Administrative law - 1981 - 412 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...shall be certified in accordance with regulations in Part 80 of this chapter. (Sees. 501, 502, 701, 706(b), (c), and (d), 52 Stat. 1049-1051 as amended,... | |
 | Administrative law - 1988 - 470 pages
...warning statement "This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic- type reactions (including bronchial asthma) in certain...shall be certified in accordance with regulations in Part 80 of this chapter. (Secs. 501, 502, 701, 706(b), (c), and (d), 52 Stat. 1049-1051 as amended,... | |
 | Administrative law - 1989 - 464 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...shall be certified in accordance with regulations in Part 80 of this chapter. (Secs. 50l, 502, 70l, 706(b), (c), and (d), 52 Stat 1049-1051 as amended,... | |
 | Administrative law - 1994 - 248 pages
...use containing FD&C Yellow No. 5 that are administer«} orally, nasally, vaginally, or rectally shall bear the warning statement "This product contains...frequently seen in patients who also have aspirin hypersensitlvity." This warning statement shall appear in the "Precautions' section of the labeling.... | |
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USP) 2.5. 5, and 10 mg contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the... 
