Nov 7 (Reuters) - The U.S. Food and Drug Administration

has proposed to remove oral phenylephrine, widely used in cold

and cough syrups, as an active ingredient in over-the-counter

drugs for nasal congestion, stating it is not effective, the

health regulator said on Thursday.

Phenylephrine is widely used in a variety of

over-the-counter flu and cold medicines, including popular

products such as Benadryl, Advil, and Tylenol.

It is also an ingredient in nasal sprays to treat

congestion. However, the FDA's action is only related to orally

administered phenylephrine and not the nasal spray form.

Last year, an outside panel of experts unanimously voted

against the effectiveness of orally administered phenylephrine

as a nasal decongestant, adding that no more trials were

required to prove otherwise.

Companies such as Procter & Gamble ( PG ) and GSK

were among several accused in lawsuits of deceiving consumers

about cold medicines containing the ingredient.

The FDA is now seeking public comments on this proposed

order.

For now, companies may continue to market drug products

containing oral phenylephrine as a nasal decongestant.

However, the FDA said it would provide manufacturers with

appropriate time to either reformulate drugs containing oral

phenylephrine or remove such drugs from the market.

Tylenol maker Kenvue ( KVUE ), GSK, Haleon ( HLN ) , and Procter

& Gamble ( PG ) did not immediately respond to Reuters' request for

comment.