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About the FDA Approved Listings

Drugs Approved by the FDA

Drug Name: Claritin Syrup (loratadine)

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Schering-Plough
Approval Status: Approved October 1996
Treatment for: seasonal allergies in children

General Information

Claritin Syrup has been approved as a non-drowsy antihistamine syrup for children as young as six years of age. In addition, the indication for Claritin tablets was expanded to include children age six years and up.

Available only by prescription in a once-daily formula, Claritin Syrup is indicated for the treatment of allergy symptoms, including itchy, watery eyes; runny nose; itchy palate; sneezing; and idiopathic chronic urticaria (hives).

Claritin Syrup, in an alcohol-free and dye-free fruit flavored formula, is administered orally at a dose of two teaspoons once-per-day for children as young as six years of age.

Clinical Results

In controlled clinical trials using the recommended dose, the incidence of the most commonly reported adverse events was comparable to placebo.


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Drug listing last updated on June 20, 2008

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