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Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of monograph for OTC nasal decongestant drug products. Final rule.
Fed Regist. 2006 Aug 01; 71(147):83358[sic., should be 43358]-63.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule to amend 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 add phenylephrine bitartrate (PEB), both individually and in combination drug products in an effervescent dosage form, as generally recognized as safe and effective (GRASE). An effervescent dosage form is intended to be dissolved in water before taking by mouth. This final rule is part of FDA's ongoing review of OTC drug products.

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MeSH

Drug LabelingHumansNasal DecongestantsNonprescription DrugsPhenylephrineUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16892519

Citation

"Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products. Final Rule." Federal Register, vol. 71, no. 147, 2006, pp. 83358[sic., should be 43358]-63.
Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of monograph for OTC nasal decongestant drug products. Final rule. Fed Regist. 2006;71(147):83358[sic., should be 43358]-63.
(2006). Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of monograph for OTC nasal decongestant drug products. Final rule. Federal Register, 71(147), 83358[, should be 43358]-63.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Amendment of Monograph for OTC Nasal Decongestant Drug Products. Final Rule. Fed Regist. 2006 Aug 1;71(147):83358[sic., should be 43358]-63. PubMed PMID: 16892519.
* 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 monograph for OTC nasal decongestant drug products. Final rule. PY - 2006/8/9/pubmed PY - 2006/8/11/medline PY - 2006/8/9/entrez SP - 83358[sic., should be 43358]-63 JF - Federal register JO - Fed Regist VL - 71 IS - 147 N2 - The Food and Drug Administration (FDA) is issuing a final rule to amend 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 add phenylephrine bitartrate (PEB), both individually and in combination drug products in an effervescent dosage form, as generally recognized as safe and effective (GRASE). An effervescent dosage form is intended to be dissolved in water before taking by mouth. This final rule is part of FDA's ongoing review of OTC drug products. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/16892519/Cold_cough_allergy_bronchodilator_and_antiasthmatic_drug_products_for_over_the_counter_human_use L2 - http://edocket.access.gpo.gov/2006/pdf/E6-12265.pdf DB - PRIME DP - Unbound Medicine ER -

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