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Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for over-the-counter nasal decongestant drug products. Final rule.
Fed Regist. 2005 Oct 11; 70(195):58974-7.FR

Abstract

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to remove the indication "for the temporary relief of nasal congestion associated with sinusitis" and to prohibit use of the terms "sinusitis" and "associated with sinusitis" elsewhere on the labeling. This final rule is part of FDA's ongoing review of OTC drug products.

Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

Drug LabelingHumansLegislation, DrugNasal DecongestantsNonprescription DrugsSinusitisUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16217879

Citation

Food and Drug Administration, HHS. "Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Amendment of Final Monograph for Over-the-counter Nasal Decongestant Drug Products. Final Rule." Federal Register, vol. 70, no. 195, 2005, pp. 58974-7.
Food and Drug Administration, HHS. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for over-the-counter nasal decongestant drug products. Final rule. Fed Regist. 2005;70(195):58974-7.
Food and Drug Administration, HHS. (2005). Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for over-the-counter nasal decongestant drug products. Final rule. Federal Register, 70(195), 58974-7.
Food and Drug Administration, HHS. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Amendment of Final Monograph for Over-the-counter Nasal Decongestant Drug Products. Final Rule. Fed Regist. 2005 Oct 11;70(195):58974-7. PubMed PMID: 16217879.
* 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; amendment of final monograph for over-the-counter nasal decongestant drug products. Final rule. A1 - ,, PY - 2005/10/13/pubmed PY - 2005/10/28/medline PY - 2005/10/13/entrez SP - 58974 EP - 7 JF - Federal register JO - Fed Regist VL - 70 IS - 195 N2 - The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to remove the indication "for the temporary relief of nasal congestion associated with sinusitis" and to prohibit use of the terms "sinusitis" and "associated with sinusitis" elsewhere on the labeling. This final rule is part of FDA's ongoing review of OTC drug products. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/16217879/Cold_cough_allergy_bronchodilator_and_antiasthmatic_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓2]

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