 | Administrative law - 1991 - 424 pages
...FD&C Yellow No. 5 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements....shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654. Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979;... | |
 | Administrative law - 1990 - 460 pages
...FD&C Yellow No. 5 may be safely used for coloring drugs generally in amounts consistent with current good manufacturing practice. (c) Labeling requirements....shall be certified in accordance with regulations in Part 80 of this chapter. [42 PR 15654, Mar. 22, 1977, as amended at 44 PR 37220, June 26, 1979;... | |
 | Administrative law - 2000 - 544 pages
...rectally, or for use in the area of the eye, the labeling required by §201.100«!) of this chapter shall, in addition to the label statement required...shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979;... | |
 | Administrative law - 1990 - 460 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. [42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979;... | |
 | 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 - 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 - 1993 - 438 pages
...contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (in§ 74.1707 eluding bronchial asthma) in certain susceptible persons....shall be certified in accordance with regulations in part 80 of this chapter. [42 FR 15654. Mar. 22. 1977, as amended at 44 FR 37220. June 26, 1979;... | |
 | 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,... | |
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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... 
