Haleon, the manufacturer of Robitussin, has agreed to a $4.5 million settlement in response to a consumer lawsuit alleging that its "non-drowsy" cough and flu medicine causes drowsiness. As part of the settlement, Haleon will remove the "non-drowsy" claim from its packaging and marketing materials.

The preliminary settlement, filed in the federal court in White Plains, New York, requires judicial approval. Although Haleon, a company spun off by GSK in July 2022, denies any wrongdoing, it has agreed to settle the case.

The proposed class action lawsuit claims that GSK, and later Haleon, mislabeled at least 16 Robitussin products containing the active ingredient dextromethorphan hydrobromide as "non-drowsy." The plaintiffs supported their claim with medical research and a 2017 GSK presentation, also noting that the Federal Aviation Administration prohibits pilots from flying after taking medications containing this ingredient.

Named plaintiffs Nancy Calchi of Bloomingburg, New York, and Stacey Papalia of Ossining, New York, asserted they would not have purchased Robitussin products if they had known the truth about the "non-drowsy" claim.

Neither Haleon nor the plaintiffs' attorneys have responded to requests for comment.

The settlement applies to Robitussin purchasers from February 16, 2016, to the present. Payouts may range from $1.50 to $4.75 per claim, depending on the number of claims submitted. Up to $2.05 million, or 46% of the settlement, could be allocated for legal fees and settlement expenses.

The lawsuit was initially dismissed by a trial judge in March 2023, leading to an appeal by the consumers. The appeal was paused as the parties negotiated the settlement, according to court documents.

The cases are Calchi v. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC et al., U.S. District Court, Southern District of New York, No. 22-01341; and Papalia v. GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, in the same court, No. 22-02630.