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Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for combination drug products. Final rule.
Fed Regist. 2002 Dec 23; 67(246):78158-72.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph that establishes conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation (tentative final monograph) and new data and information on OTC cough- cold combination drug products that have come to the agency's attention.

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

AnalgesicsAnti-Asthmatic AgentsAntitussive AgentsBronchodilator AgentsCholinergic AntagonistsDrug ApprovalDrug LabelingDrug Therapy, CombinationHistamine H1 AntagonistsHumansNasal DecongestantsNonprescription DrugsUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

12508820

Citation

Food and Drug Administration, HHS. "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Final Monograph for Combination Drug Products. Final Rule." Federal Register, vol. 67, no. 246, 2002, pp. 78158-72.
Food and Drug Administration, HHS. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for combination drug products. Final rule. Fed Regist. 2002;67(246):78158-72.
Food and Drug Administration, HHS. (2002). Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for combination drug products. Final rule. Federal Register, 67(246), 78158-72.
Food and Drug Administration, HHS. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Final Monograph for Combination Drug Products. Final Rule. Fed Regist. 2002 Dec 23;67(246):78158-72. PubMed PMID: 12508820.
* 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; final monograph for combination drug products. Final rule. A1 - ,, PY - 2003/1/2/pubmed PY - 2003/1/18/medline PY - 2003/1/2/entrez SP - 78158 EP - 72 JF - Federal register JO - Fed Regist VL - 67 IS - 246 N2 - The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph that establishes conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on the agency's proposed regulation (tentative final monograph) and new data and information on OTC cough- cold combination drug products that have come to the agency's attention. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/12508820/Cold_cough_allergy_bronchodilator_and_antiasthmatic_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -