“FDA Clarifies Results of Recent Advisory Committee Meeting on Oral Phenylephrine”, 2023-09-14 (; backlinks):
The FDA held a Non-prescription Drug Advisory Committee meeting Sept. 11–12, 2023, to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter (OTC) cough and cold products that are indicated for the temporary relief of congestion, both as a single ingredient product and in combination with other ingredients.
The committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data do not support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant.
…Consumers should know there is a range of products that are available for temporary relief of congestion symptoms due to allergies or a common cold. Consumers should also know that some products only contain phenylephrine. Other products contain phenylephrine and another active ingredient (eg. acetaminophen or ibuprofen) that treats symptoms other than congestion like headaches or muscle aches, and the presence of phenylephrine in these products does not affect how other active ingredients work to treat those symptoms. Because a variety of different drug products may be sold under the same brand name, consumers should always read the drug facts label to determine which ingredients are in a medication, as well as important warnings and directions for use.
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