USAALLERZ^® 180

COMPOSITION: Each film-coated tablet contains:

Fexofenadine hydrochloride..................... 180 mg

Excipients: Lactose, Microcrystalline cellulose, Croscarmellose sodium, Colloidal anhydrous silica, Talc, Magnesium stearate, Opadry II pink q.s. one tablet.

INDICATIONS

Seasonal Allergic Rhinitis

USAALLERZ^® 180 tablets (fexofenadin hydroclorid 180 mg) are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older as follows:

• Red, itchy and watery eyes.
• Stuffy, runny nose, sneezing.
• Itchy mouth, throat, ears and face.

Chronic Idiopathic Urticaria

USAALLERZ^® 180 tablets (fexofenadin hydroclorid 180 mg) are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 12 years of age and older.

DOSAGE AND ADMINISTRATION

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Adults and Children 12 Years and Older: The recommended dose is 1 tablet of USAALLERZ^® 180 once daily with water.

CONTRAINDICATIONS

Hypersensitive to fexofenadine or any ingredient in the formulation.

WARNING AND PRECAUTIONS

Although no adverse cardiovascular effects have been observed with USAALLERZ^® 180, USAALLERZ^® 180 should be used with caution in patient with high risk cardiac disease or QT-interval prolongation.

Based on increases in bioavailability and half-life, a dose adjustment is recommended as the starting dose in patients with decreased renal function.

Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

The safety and effectiveness of this medication in pediatric patients under 6 months of age have not been established.

USAALLERZ^® 180 should be stopped for at least 24-48 hours prior to intradermal antigen testing.

Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations.

Pregnancy

There are no adequate and well controlled studies in pregnant women. Fexofenadine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known if fexofenadine is excreted in human milk. Thus, caution should be exercised when fexofenadine hydrochloride is administered to a nursing woman.

PRESENTATION: Blister of 10 film-coated tablets; box of 1 blisters.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Manufactured and Distributed by: AMPHARCO U.S.A PHARMACEUTICAL JOINT-STOCK COMPANY

Nhon Trach 3 Industrial Park, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province

Tel: 02513 566 202    -     Fax: 02513 566 203