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Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products. Food and Drug Administration, HHS. Final rule.
Fed Regist. 2000 Aug 01; 65(148):46864-8.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antitussive drug products (products that relieve cough). Use of topical/inhalant products containing camphor or menthol near a flame, in hot water, or in a microwave oven may cause the products to splatter and cause serious burns to the user. As part of its ongoing review of OTC drug products, FDA is adding warnings and directions to inform consumers about these improper uses and is amending its final regulations for OTC drug labeling requirements to add this new flammability warning for antitussive drug products containing camphor or menthol.

MeSH

Anti-Asthmatic AgentsAntitussive AgentsBurns, ChemicalCamphorConsumer Product SafetyHumansMentholNonprescription DrugsProduct LabelingUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

11067707

Citation

"Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Amendment of Final Monograph for OTC Antitussive Drug Products. Food and Drug Administration, HHS. Final Rule." Federal Register, vol. 65, no. 148, 2000, pp. 46864-8.
Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products. Food and Drug Administration, HHS. Final rule. Fed Regist. 2000;65(148):46864-8.
(2000). Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; amendment of final monograph for OTC antitussive drug products. Food and Drug Administration, HHS. Final rule. Federal Register, 65(148), 46864-8.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use; Amendment of Final Monograph for OTC Antitussive Drug Products. Food and Drug Administration, HHS. Final Rule. Fed Regist. 2000 Aug 1;65(148):46864-8. PubMed PMID: 11067707.
* 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 OTC antitussive drug products. Food and Drug Administration, HHS. Final rule. PY - 2000/11/7/pubmed PY - 2000/11/7/medline PY - 2000/11/7/entrez SP - 46864 EP - 8 JF - Federal register JO - Fed Regist VL - 65 IS - 148 N2 - The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph for over-the-counter (OTC) antitussive drug products (products that relieve cough). Use of topical/inhalant products containing camphor or menthol near a flame, in hot water, or in a microwave oven may cause the products to splatter and cause serious burns to the user. As part of its ongoing review of OTC drug products, FDA is adding warnings and directions to inform consumers about these improper uses and is amending its final regulations for OTC drug labeling requirements to add this new flammability warning for antitussive drug products containing camphor or menthol. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/11067707/Cold_cough_allergy_bronchodilator_and_antiasthmatic_drug_products_for_over_the_counter_human_use DB - PRIME DP - Unbound Medicine ER -
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