CLARITIN is indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients 2 years of age or older.

Adults and children 6 years of age and over: The recommended dose of CLARITIN is one 10 mg tablet or reditab, or 2 teaspoonfuls (10 mg) of syrup once daily.

Children 2 to 5 years of age: The recommended dose of CLARITIN Syrup is 5 mg (1 teaspoonful) once daily.

In adults and children 6 years of age and over with liver failure or renal insufficiency (GFR < 30 mL/min), the starting dose should be 10 mg (one tablet or two teaspoonfuls) every other day. In children 2 to 5 years of age with liver failure or renal insufficiency, the starting dose should be 5 mg (one teaspoonful) every other day.

Administration of CLARITIN REDITABS (loratadine rapidly-disintegrating tablets): Place CLARITIN REDITABS (loratadine rapidly-disintegrating tablets) on the tongue. Tablet disintegration occurs rapidly. Administer with or without water.

CLARITIN Tablets: 10 mg, white to off-white compressed tablets; impressed with the product identification number “458” on one side and “CLARITIN 10” on the other; high-density polyethylene plastic bottles of 100 (NDC 0085-0458-03) and 500 (NDC 0085-0458-06). Also available, CLARITIN Unit-of-Use packages of 30 tablets (10 tablets per blister card) (NDC 0085-0458-05); and 10 x 10 tablet Unit Dose-Hospital Pack (NDC 0085-0458-04).

Protect Unit-of-Use packaging and Unit Dose-Hospital Pack from excessive moisture.

Store between 2° and 30°C (36° and 86°F).

CLARITIN Syrup: Clear, colorless to light-yellow liquid, containing 1 mg loratadine per mL; amber glass bottles of 16 fluid ounces (NDC 0085-1223-01).

Store between 2° and 25°C (36° and 77°F).

CLARITIN REDITABS (loratadine rapidly-disintegrating tablets): CLARITIN REDITABS (loratadine rapidly-disintegrating tablets), 10 mg, white to off-white blister-formed tablet; impressed with the letter “C” on one side; Unit-of-Use polyvinyl chloride blister packages of 30 tablets (three laminated foil pouches, each containing one blister card of 10 tablets) supplied with Patient's Instructions for Use (NDC 0085-1128-02).

Keep CLARITIN REDITABS (loratadine rapidly-disintegrating tablets) in a dry place.

Store between 2° and 25°C (36° and 77°F). Use within 6 months of opening laminated foil pouch, and immediately upon opening individual tablet blister.

Schering Corporation Kenilworth, NJ 07033, USA. Rev. 9/00. FDA rev date:

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