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Home » FDA PROPOSES CHANGES TO LABELING OF OTC NASAL DECONGESTANTS
FDA PROPOSES CHANGES TO LABELING OF OTC NASAL DECONGESTANTS
July 30, 2004
The FDA is proposing to amend the final monograph for OTC nasal-decongestant drug products to remove the indication “for the temporary relief of nasal congestion associated with sinusitis” and to prohibit use of the terms “sinusitis” and “associated sinusitis” elsewhere in the labeling.