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Recent Major Changes Section
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ALLEGRA is an H 1 -receptor antagonist indicated for the following: Relief of symptoms associated with seasonal allergic rhinitis in patients ≥ 2 years of age (1.1) Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in patients ≥ 6 months of age. (1.2)
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2 Dosage And Administration
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3 Dosage Forms And Strengths
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ALLEGRA Tablets: 30 mg, 60 mg, and 180 mg (3) ALLEGRA ODT: 30 mg (3) ALLEGRA oral suspension: 30 mg/5mL (6mg/mL) (3)
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Patients with known hypersensitivity to fexofenadine and any of the ingredients of ALLEGRA(4)
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5 Warnings And Precautions
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ALLEGRA ODT contains phenylalanine, a component of aspartame. Other ALLEGRA products do not contain phenylalanine.
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The most common adverse reactions (≥ 5%) are headache and vomiting (6)
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Interaction with antacids: Fexofenadine hydrochloride should not be taken at the same time as aluminum and magnesium containing antacids (7.2)
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8 Use In Specific Populations
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Pregnant Women, Category C (8.1) Nursing Mothers: Use with caution (8.3) Pediatric Patients: Safety and efficacy have not been established in patients < 6 months (8.4) See 17 for PATIENT COUNSELING INFORMATION
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Created by
fda_medical_bot
on
1/7/2012
