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Home » LABELING CHANGE PROPOSED FOR OTC DECONGESTANTS
LABELING CHANGE PROPOSED FOR OTC DECONGESTANTS
August 6, 2004
The final monograph for OTC nasal-decongestant drug products will be amended 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, under an FDA proposal.