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Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; partial final rule for combination drug products containing a bronchodilator. Final rule.
Fed Regist. 2001 Sep 27; 66(188):49276-8.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing that cough-cold combination drug products containing any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. FDA is issuing this final rule after receiving no public comments on the agency's proposed nonmonograph status of these specific combination drug products, which was issued in the form of a tentative final monograph for OTC cough-cold combination drug products. This final rule is part of the ongoing review of OTC drug products conducted by FDA.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

11758596

Citation

Food and Drug Administration, HHS. "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Partial Final Rule for Combination Drug Products Containing a Bronchodilator. Final Rule." Federal Register, vol. 66, no. 188, 2001, pp. 49276-8.
Food and Drug Administration, HHS. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; partial final rule for combination drug products containing a bronchodilator. Final rule. Fed Regist. 2001;66(188):49276-8.
Food and Drug Administration, HHS. (2001). Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; partial final rule for combination drug products containing a bronchodilator. Final rule. Federal Register, 66(188), 49276-8.
Food and Drug Administration, HHS. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Partial Final Rule for Combination Drug Products Containing a Bronchodilator. Final Rule. Fed Regist. 2001 Sep 27;66(188):49276-8. PubMed PMID: 11758596.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; partial final rule for combination drug products containing a bronchodilator. Final rule. A1 - ,, PY - 2002/1/5/pubmed PY - 2002/1/5/medline PY - 2002/1/5/entrez SP - 49276 EP - 8 JF - Federal register JO - Fed Regist VL - 66 IS - 188 N2 - The Food and Drug Administration (FDA) is issuing a final rule establishing that cough-cold combination drug products containing any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. FDA is issuing this final rule after receiving no public comments on the agency's proposed nonmonograph status of these specific combination drug products, which was issued in the form of a tentative final monograph for OTC cough-cold combination drug products. This final rule is part of the ongoing review of OTC drug products conducted by FDA. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/11758596/Cold_cough_allergy_bronchodilator_and_antiasthmatic_drug_products_for_over_the_counter_human_use L2 - http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register&docid=01-24127-filed.pdf DB - PRIME DP - Unbound Medicine ER -