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Labeling for bronchodilators to treat asthma; cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Final rule.
Fed Regist. 2011 Jul 26; 76(143):44475-89.FR

Abstract

The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an "Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products.

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Authors

Food and Drug Administration, HHS
No affiliation info available

MeSH

Anti-Allergic AgentsAnti-Asthmatic AgentsAntitussive AgentsAsthmaBronchodilator AgentsCommon ColdCoughDrug LabelingEphedrineEpinephrineHumansLegislation, DrugNonprescription DrugsRacepinephrineUnited StatesUnited States Food and Drug Administration

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21796845

Citation

Food and Drug Administration, HHS. "Labeling for Bronchodilators to Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use. Final Rule." Federal Register, vol. 76, no. 143, 2011, pp. 44475-89.
Food and Drug Administration, HHS. Labeling for bronchodilators to treat asthma; cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Final rule. Fed Regist. 2011;76(143):44475-89.
Food and Drug Administration, HHS. (2011). Labeling for bronchodilators to treat asthma; cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Final rule. Federal Register, 76(143), 44475-89.
Food and Drug Administration, HHS. Labeling for Bronchodilators to Treat Asthma; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-counter Human Use. Final Rule. Fed Regist. 2011 Jul 26;76(143):44475-89. PubMed PMID: 21796845.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Labeling for bronchodilators to treat asthma; cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Final rule. A1 - ,, PY - 2011/7/30/entrez PY - 2011/7/30/pubmed PY - 2011/8/19/medline SP - 44475 EP - 89 JF - Federal register JO - Fed Regist VL - 76 IS - 143 N2 - The Food and Drug Administration (FDA) is amending the final monograph (FM) for over-the-counter (OTC) bronchodilator drug products to add additional warnings (e.g., an "Asthma alert'') and to revise the indications, warnings, and directions in the labeling of products containing the ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, epinephrine, epinephrine bitartrate, racephedrine hydrochloride, and racepinephrine hydrochloride. FDA is issuing this final rule after considering data and information submitted in response to the Agency's proposed labeling revisions for these products. This final rule is part of FDA's ongoing review of OTC drug products. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/21796845/Labeling_for_bronchodilators_to_treat_asthma L2 - http://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18347.pdf DB - PRIME DP - Unbound Medicine ER -

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