"Jan. 25, 2011 -- The FDA today approved over-the-counter sale of Allegra, the best-selling antihistamine also sold generically as fexofenadine.
Allegra maker Sanofi-aventis says Allegra will be on retail shelves on March 4, in plenty of"...
Patients taking ALLEGRA-D (fexofenadine hcl and pseudoephedrine hcl) 12 HOUR tablets should receive the following information: ALLEGRA-D (fexofenadine hcl and pseudoephedrine hcl) 12 HOUR tablets are prescribed for the relief of symptoms of seasonal allergic rhinitis. Patients should be instructed to take ALLEGRA-D (fexofenadine hcl and pseudoephedrine hcl) 12 HOUR tablets only as prescribed. Do not exceed the recommended dose. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult the doctor. Patients should also be advised against the concurrent use of ALLEGRA-D (fexofenadine hcl and pseudoephedrine hcl) 12 HOUR tablets with over-the-counter antihistamines and decongestants.
The product should not be used by patients who are hypersensitive to it or to any of its ingredients. Due to its pseudoephedrine component, this product should not be used by patients with narrow-angle glaucoma, urinary retention, or by patients receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of MAO inhibitor. It also should not be used by patients with severe hypertension or severe coronary artery disease.
Patients should be told that this product should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant. Patients should be advised to take the tablet on an empty stomach with water. Patients should be directed to swallow the tablet whole. Patients should be cautioned not to break or chew the tablet. Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children.
Patients should be told that the inactive ingredients may occasionally be eliminated in the feces in a form that may resemble the original tablet (see DOSAGE AND ADMINISTRATION).
Last reviewed on RxList: 5/10/2010
This monograph has been modified to include the generic and brand name in many instances.
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