The company intends to initiate shipments of the product prior to the upcoming cough/cold/flu season.
Advil Congestion Relief Tablets, 200mg/10mg, (ibuprofen & phenylephrine hydrochloride tablets, 200mg/10mg) is indicated for the relief of sinus pressure, nasal swelling and congestion, and headache.
According to the company, estimated annual sales of the product are about $18m.
Perrigo chairman, president and CEO Joseph Papa said, "This approval further strengthens our leading store brand position and highlights our commitment to bringing new affordable products to the market."
The company develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, nutritional products and active pharmaceutical ingredients (API), and receives royalties from Multiple Sclerosis drug Tysabri.