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Executive Summary

OTC DECONGESTANT WARNING AGAINST USE WHEN FEVER PRESENT should be omitted in the final monograph for nasal decongestants, Bristol-Myers asserted in May 3 comments to FDA on the Tentative Final Monograph for OTC Nasal Decongestant Drug Products published in the Jan. 15 Federal Register. Bristol-Myers stated that the proposed warning against use of decongestants in patients with fever should be reworded in the final monograph "to explicitly permit use of orally administered Category I nasal decongestants along with antipyretic agents when there are present concurrent symptoms of fever and nasal congestion." The proposed warning, Bristol-Myers contended, "would have a serious and unwarranted adverse effect on the use of combination products containing a nasal decongestant along with an analgestic/antipyretic." Asserting that the common cold is often accompanied by fever and nasal congestion, Bristol-Myers stated that "a warning against even temporary use of a combination product under such conditions would deprive the consumer of the benefits of self-medication." Also commenting on the decongestant tentative final, Miles urged that phenylephrine bitartrate be classified as Category I in the final monograph. Miles stated that the omission of phenylephrine bitartrate in the proposed decongestant rule "appears to be inadvertent" because, "while not as commonly used as the hydrochloride salt of phenylephrine, [it has] the same characteristics."

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