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Taro Pharma OTC allergy drug gets FDA approval

Taro Pharmaceutical Industries has obtained the US Food and Drug Administration's (FDA) approval for its abbreviated new drug application (ANDA) for its over-the-counter (OTC) Cetirizine Hydrochloride oral solution, 1mg/ml (Sugar Free Bubble Gum).

Cetirizine Oral Solution is an antihistamine, indicated for the relief sneezing, runny nose, itchy, watery eyes and itchy throat or nose due to indoor and outdoor allergies and for the relief of itching due to hives.

Taro’s Cetirizine Hydrochloride oral solution is bioequivalent to McNeil Consumer Healthcare’s Zyrtec Syrup, 5mg/5ml for Children.

Zyrtec Syrup is an antihistamine that works by blocking the action of histamine and reduces the symptoms of an allergic reaction.