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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... "
The Code of Federal Regulations of the United States of America - Page 16
2000
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The Code of Federal Regulations of the United States of America

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...human use administered orally, nasally, rectally, or vaglnally containing FD&C Yellow No. 6 shall specifically declare the presence of FD&C Yellow No. 6...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1981 - 254 pages
...human 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. (Sees. 501, 502. 701, 706(b), (c), and (d), 52 Stat. 1049-1051 as amended, 1055-1056 as amended, 74...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2002 - 532 pages
...chapter shall, in addition to the label statement required under paragraph (c)(2) of this section, bear the warning statement "This product contains...appear in the "Precautions" section of the labeling. (d) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 2000 - 544 pages
...chapter shall, in addition to the label statement required under paragraph (c)(2) of this section, bear the warning statement "This product contains...appear in the "Precautions" section of the labeling. (d) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations...
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The Code of Federal Regulations of the United States of America

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...appear in the "Precautions" section of the labeling. (d) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations...
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The Code of Federal Regulations of the United States of America

Administrative law - 1989 - 240 pages
...human use containing FD&C Yellow No. 5 that are administered orally, nasally, vaginally, or rectally shall bear the warning statement "This product contains...general population is low, it is frequently seen in pa§201.22 tients who also have aspirin hypersensitivity." This warning statement shall appear in the...
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The Code of Federal Regulations of the United States of America

Administrative law - 1993 - 436 pages
...contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (in§ 74.1707 eluding bronchial asthma) in certain susceptible persons....appear in the "Precautions" section of the labeling. (d) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations...
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Code of Federal Regulations: Containing a Codification of Documents of ...

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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1989 - 464 pages
...rectally shall, in addition to the label statement required under paragraph (c)(2) of this section, bear the warning statement "This product contains...appear in the "Precautions" section of the labeling. (d) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations...
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Code of Federal Regulations: Containing a Codification ..., Issue 21, Parts 1-99

Administrative law - 1993 - 440 pages
...this section, bear the warning statement "This product contains FD&C Yellow No. 5 (tartrazine) which cause allergic-type reactions (including bronchial...appear in the "Precautions" section of the labeling. (d) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations...
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