USAALLERZ^® 60

COMPOSITION: Each film-coated tablet contains:

Fexofenadine hydrochloride........................ 60 mg

Excipients: Corn starch, Pregelatinised starch, Lactose, Croscarmellose sodium, Colloidal anhydrous silica, Talc, Magnesium stearate, Opadry II white, Red iron oxide, Yellow iron oxide, qs. one tablet.

INDICATIONS

• Seasonal Allergic Rhinitis

USAALLERZ^® 60 tablets (fexofenadine hydrochloride) 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^® 60 tablets (fexofenadine hydrochloride) 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 60 mg twice daily or 120 - 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.

CONTRAINDICATIONS

Hypersensitive to fexofenadine or any ingredient in the formulation.

WARNING AND PRECAUTIONS

Although no adverse cardiovascular effects have been observed with fexofenadine, fexofenadine 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 fexofenadine hydrochloride in pediatric patients under 6 months of age have not been established.

Fexofenadine should be stopped for at least 24-48 hours prior to intradermal antigen testing.

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 3 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 -PJSC

Nhon Trach 3 Industrial Park, Hiep Phuoc, Nhon Trach, Dong Nai.

Tel: 02513 566 202    -     Fax: 02513 566 203