‘Advil Cold & Sinus Day/Night’ packs recalled over ‘labelling error,’ Health Canada says

A picture of one of the affected GSK Advil products. Health Canada

Health Canada says GlaxoSmithKline (GSK) is recalling two lots of its “Advil Cold & Sinus Day/Night Convenience Packs” after a packaging error left the daytime caplets labelled as nighttime caplets and vice versa.

GSK says the labelling error is located on the back of its 18 and 36 caplet boxes, with the foil on the products’ blister pack “rotated upside down and misaligned.”

“Consumers may take a nighttime caplet instead of a daytime caplet, and vice versa. Taking a nighttime caplet when alertness is required may pose health risks,” the recall stated.

Health Canada says to immediately stop using the recalled items and to consult a health care professional if they’ve used the product and have any concerns.

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According to the agency, the affected products were shipped across Canada starting in July of 2021.

“The nighttime caplets contain an antihistamine medicinal ingredient (chlorpheniramine maleate) that can cause drowsiness,” read Health Canada’s warning.

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“Taking a nighttime caplet when alertness is required may pose potentially serious adverse health consequences, such as when driving motor vehicles or operating heavy machinery. It may also cause potentially serious health consequences for those who have taken other sedatives or tranquilizers, consumed alcohol, and the elderly.”

Health Canada said that the daytime and nighttime caplets differ from one another in shape and colour. The daytime caplet is beige and marked by “ADVIL COLD & SINUS” while the nighttime is orange and marked by “Advil A/S.”

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