federal_register: 05-20304

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
05-20304 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 Rule 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. 2005-10-11 2005 10 https://www.federalregister.gov/documents/2005/10/11/05-20304/cold-cough-allergy-bronchodilator-and-antiasthmatic-drug-products-for-over-the-counter-human-use https://www.govinfo.gov/content/pkg/FR-2005-10-11/pdf/05-20304.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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