(Update) Several lots of Advil Cold & Sinus Day/Night Convenience Pack recalled due to labelling error that may cause confusion between daytime and nighttime tablets

GlaxoSmithKline Consumer Healthcare ULC (GSK) is recalling two lots of Advil Cold & Sinus Day/Night Convenience Pack (one lot of 18 caplet boxes and one lot of 36 caplet boxes) due to a labelling error on blister packs. The foil backing on the blister pack is rotated upside down and misaligned, so the nighttime caplets are labelled as daytime caplets, and some daytime caplets are labelled as nighttime caplets. Consumers may take a nighttime caplet when they intend to take a daytime caplet, and vice versa. The daytime and nighttime caplets have a different shape and colour (the daytime caplet is beige and has the marking ‘ADVIL COLD & SINUS’ in black ink. The nighttime caplet is orange and has the marking ‘Advil A/S’). The nighttime caplets contain an antihistamine medicinal ingredient (chlorpheniramine maleate) that can cause drowsiness. 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. The affected products were distributed in Canada starting July 2021. Health Canada is monitoring the company’s recall and implementation of any necessary corrective and preventive actions.

• Stop using the recalled products. Consult a health care professional if you have used any of these products and have health concerns.
  • Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste; or
  • Return the product to your local pharmacy for proper disposal.
• Contact GSK by calling 1-855-367-7349, or emailing ca.customer-relations@gsk.com, if you have questions about the recall.
• Report any health product-related side effects or complaints to Health Canada.

Brand name: Advil Cold and Sinus Convenience Pack
Dosage form: Tablet
Strength:

• Chloropheniramine Maleate 2 mg
• Ibuprofen 200 mg
• Pseudoephedrine Hydrochloride 30 mg

DIN, NPN, DIN-HIM: DIN 02399733
Lot or serial number:

• ER2069
• ER2072

Affected products