ALLEGRA fexofenadine hydrochloride

Get an overview of ALLEGRA (fexofenadine hydrochloride suspension), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in ALLEGRA can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as ALLEGRA.

Drug Basics

Brand Name: ALLEGRA

Generic Name: FEXOFENADINE HYDROCHLORIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: SUSPENSION

Data Current As Of: 2018-10-05

indications & usage

seasonal allergic rhinitis

ALLEGRA is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.

chronic idiopathic urticaria

ALLEGRA is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

warnings & precautions

phenylketonurics

ALLEGRA ODT contains phenylalanine, a component of aspartame. Each 30 mg ALLEGRA ODT contains 5.3 mg phenylalanine. ALLEGRA products other than ALLEGRA ODT do not contain phenylalanine.

patient counseling information

Provide the following information to patients and parents/caregivers of pediatric patients taking ALLEGRA tablets, ALLEGRA ODT or ALLEGRA oral suspension:

  • ALLEGRA tablets, ALLEGRA ODT or ALLEGRA oral suspension are prescribed for the relief of symptoms of seasonal allergic rhinitis or for the relief of symptoms of chronic idiopathic urticaria (hives). Instruct patients to take ALLEGRA only as prescribed. Do not exceed the recommended dose.If any untoward effects occur while taking ALLEGRA, discontinue use and consult a doctor.

  • Patients who are hypersensitive to any of the ingredients should not use these products.

  • Patients who are pregnant or nursing should use these products only if the potential benefit justifies the potential risk to the fetus or nursing infant.

  • Advise patients and parents/caregivers of pediatric patients to store the medication in a tightly closed container in a cool, dry place, away from small children.

  • Advise patients and parents/caregivers not to take ALLEGRA with fruit juices.

For ALLEGRA tablets: Advise patients to take the ALLEGRA tablets with water.

For ALLEGRA ODT: Advise patients to take their dose on an empty stomach. Allow ALLEGRA ODT to disintegrate on the tongue before swallowing, with or without water. ALLEGRA ODT is not intended to be chewed. Store ALLEGRA ODT in its original blister package. Do not remove ALLEGRA ODT from the original blister package until the time of administration.

Phenylketonurics: ALLEGRA ODT contains phenylalanine, a component of aspartame. Each 30-mg ALLEGRA ODT contains 5.3 mg phenylalanine. ALLEGRA products other than ALLEGRA ODT do not contain phenylalanine.

For ALLEGRA oral suspension: Advise patients and parents/caregivers of pediatric patients to shake the ALLEGRA oral suspension bottle well, before each use.

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

ALLEGRA ODT manufactured for:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

©2007 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 10 Blister Carton

NDC 0088-1113-30

Rx ONLY

allegra ®
fexofenadine HCl

ODT Orally Disintegrating Tablets, 30 mg

Ten 6 Tablet Blisters

sanofi aventis

allegra odt 06.jpg

PRINCIPAL DISPLAY PANEL - 30 mg Bottle Label

NDC 0088-1106-47

allegra ®
fexofenadine hydrochloride
Tablets

30mg

100 Tablets

sanofi aventis

allegra odt 02.jpg

PRINCIPAL DISPLAY PANEL - 60 mg Bottle Label

NDC 0088-1107-47

allegra ®
fexofenadine hydrochloride
Tablets

60mg

100 Tablets

sanofi aventis

allegra odt 03.jpg

PRINCIPAL DISPLAY PANEL - 180 mg Bottle Label

NDC 0088-1109-47

allegra ®
fexofenadine
hydrochloride

Tablets

180mg

100 Tablets

sanofi aventis

allegra odt 04.jpg

PRINCIPAL DISPLAY PANEL - 300 mL Bottle Label

NDC 0088-1097-20

allegra ®
fexofenadine HCl
Oral Suspension, 30mg/5mL (6mg/mL)

One 300mL Bottle

sanofi aventis

SHAKE WELL BEFORE USING

Rx ONLY

Each mL of ALLEGRA® Oral Suspension contains 6mg
of fexofenadine hydrochloride

Dosage and Administration: See package insert.

WARNING: Keep out of reach of children.

Pharmacist: Dispense in light-resistant, tight
container with child-resistant closure.

Store at controlled room temperature 20–25°C
(68–77°F). [See USP Controlled Room
Temperature].

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807
©2008
50087397

allegra odt 05.jpg

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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