DUBLIN, Ireland — Perrigo Co. plc has received approval from the Food and Drug Administration for hydrocodone bitartrate and homatropine methylbromide oral solution 5 mg/1.5 mg per 5 ml.

Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough in adults and children ages 6 and older. A combination medication, the narcotic (hydrocodone) alleviates the cough symptoms while the other medicine (homatropine) works against the narcotic to prevent an overdose.

U.S. sales of hydrocodone bitartrate and homatropine methylbromide syrup totaled approximately $16 million for the 12 months ending in January, Perrigo reported.

“This final approval is another example of Perrigo’s ongoing commitment to developing high-quality value alternatives in important treatment categories,” Perrigo chief executive officer John Hendrickson stated. “The Rx team continues to leverage the company’s development capabilities in order to deliver quality affordable health care products to our customers and consumers around the world.”