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.
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.
D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug; D014663:Nasal Decongestants / Q000627:therapeutic use*; D004366:Nonprescription Drugs / Q000627:therapeutic use*; D012852:Sinusitis / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
D014663:Nasal Decongestants; D004366:Nonprescription Drugs