Active Ingredient in Hundreds of Cold and Flu Meds Is ‘Entirely Ineffective,’ Class Action Says

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Fourteen companies that make and/or sell over-the-counter cold and flu medicines face a proposed class action in the wake of an FDA advisory panel announcement that the active ingredient phenylephrine is wholly ineffective at treating nasal congestion.

If you’ve bought cold and flu medicine containing phenylephrine, let us know here.

The 19-page case alleges in particular that the makers of several popular medications—such as Tylenol, Sudafed, Advil and Dayquil—have for years marketed their products as effective at relieving nasal congestion and other cold and flu symptoms, despite knowing that phenylephrine works no better than a placebo.

The lawsuit was filed in California on September 12, the same day an FDA advisory committee concluded a two-day review of existing scientific studies on phenylephrine with a unanimous vote that the ingredient does not work to treat nasal congestion.

According to the suit, phenylephrine is used as an active ingredient in at least 250 cold and flu products, including, but not limited to: 

• Sudafed Sinus Congestion;
• Tylenol Cold & Flu Severe;
• Nyquil Severe Cold & Flu;
• Theraflu Severe Cold Relief; and
• Mucinex Sinus Max.

The purported decongestant is also found in products sold under generic brand names developed by major retailers such as CVS, Walmart, Target and Walgreens, as well as medicines sold under brand names like Benadryl, Robitussin, Theraflu, Contac, Advil, Alka-Seltzer, Allegra and Zicam, the filing says.

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The complaint names as defendants Johnson & Johnson, GlaxoSmithKline, Reckitt Benckiser, Bayer Healthcare, Sanofi, Procter & Gamble, Church & Dwight Co., Walmart, Target, CVS Pharmacy, Walgreens, Albertsons Companies, Rite Aid and Amazon.com.

As a result of the defendants’ alleged misrepresentations, hundreds of millions of unsuspecting Americans have spent their “hard-earned money” to treat cold and flu symptoms using medications with an active ingredient that is “entirely ineffective” for that purpose, the filing contends.

Phenylephrine is reportedly the most popular oral decongestant in the United States, generating nearly $1.8 billion in sales in 2022, according to data shared by FDA officials. The FDA panel’s vote stems from evidence that showed that when phenylephrine is taken orally, only a minimal amount of the drug reaches the nose to relieve congestion.

The FDA’s next step is to decide whether to revoke phenylephrine’s status as “generally recognized as safe and effective,” a tag that allows drugmakers to include an ingredient in over-the-counter medications without needing to go through the regulator.

The lawsuit looks to represent anyone in the United States who purchased any of the phenylephrine products mentioned on this page.

How can I join the lawsuit?

There’s usually nothing you need to do to join or be included in a proposed class action lawsuit when it’s first filed. It’s only if and when the case settles that a consumer might have to take action, typically by filling out and filing a claim form online or by mail. If a settlement is reached, anyone who has been affected by the case, i.e., the “class members,” may receive direct notice with instructions on how to proceed and information on their legal rights.

If you’ve bought cold and flu medicine containing phenylephrine, let us know here.