Fexofenadine (Fexofenadine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Seasonal Allergic Rhinitis

Fexofenadine Hydrochloride Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

Chronic Idiopathic Urticaria

Fexofenadine Hydrochloride Tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. It significantly reduces pruritus and the number of wheals.

DOSAGE AND ADMINISTRATION

Seasonal Allergic Rhinitis

Adults and Children 12 Years and Older

The recommended dose of Fexofenadine Hydrochloride Tablets is 60 mg twice daily, or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function (see CLINICAL PHARMACOLOGY).

Children 6 to 11 Years

The recommended dose of Fexofenadine Hydrochloride Tablets is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function (see CLINICAL PHARMACOLOGY).

Chronic Idiopathic Urticaria

Adults and Children 12 Years and Older

The recommended dose of Fexofenadine Hydrochloride Tablets is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function (see CLINICAL PHARMACOLOGY).

Children 6 to 11 Years

The recommended dose of Fexofenadine Hydrochloride Tablets is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function (see CLINICAL PHARMACOLOGY).

HOW SUPPLIED

Fexofenadine Hydrochloride Tablets 30 mg are available in HDPE bottles of 100 (NDC 66993-106-02) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal.

Fexofenadine Hydrochloride Tablets 60 mg are available in HDPE bottles of 100 (NDC 66993-107-02) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal and HDPE bottles of 500 (NDC 66993-104-04) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal.

Fexofenadine Hydrochloride Tablets 180 mg are available in HDPE bottles of 100 (NDC 66993-109-02) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal and HDPE bottles of 500 (NDC 66993-109-04) with a polypropylene screw cap containing a pulp/wax liner with heat-sealed foil inner seal.

Fexofenadine Hydrochloride Tablets are coated with a peach colored film coating. Tablets have the following unique identifiers: 30 mg tablets have 03 on one side, 60 mg tablets have 06 on one side, and 180 mg tablets have 018 on one side.

Store Fexofenadine Hydrochloride Tablets at controlled room temperature 20–25°C (68–77°F). (See USP Controlled Room Temperature). Fexofenadine Hydrochloride Tablets should be protected from excessive moisture.