No

Antihistamine/Decongestant Combination

Relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.

C

Oral: Adults: One tablet twice daily for adults and children 12 years of age and older. It is recommended that the administration with food should be avoided. A dose of one tablet once daily is recommended as the starting dose in patients with decreased renal function.

Pseudoephedrine component: Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response

Pseudoephedrine component: Up to 10% of patients could experience tachycardia, palpitations, and dry mouth; use vasoconstrictor with caution

Patients should be instructed to take tablets only as prescribed. Do not exceed the recommended dose. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult the physician. Patients should also be advised against the concurrent use of the 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 cautioned not to break or chew the tablet. Patients should be directed to swallow the tablet whole. Patients should be instructed not to take the tablet with food. Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children.

Tablet, extended release: Fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg