ALLEGRA

ALLEGRA (fexofenadine hydrochloride) is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. ALLEGRA (fexofenadine hydrochloride) is a racemate and exists as a zwitterion in aqueous media at physiological pH.

ALLEGRA (fexofenadine hcl) is formulated as a tablet for oral administration. Each tablet contains 30, 60, or 180 mg ALLEGRA (fexofenadine hydrochloride) (depending on the dosage strength) and the following excipients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The aqueous tablet film coating is made from hypromellose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide.

ALLEGRA (fexofenadine hcl) ODT is formulated for disintegration in the mouth immediately following administration. Each orally disintegrating tablet contains 30 mg ALLEGRA (fexofenadine hydrochloride) and the following excipients: citric acid anhydrous, crospovidone, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium starch glycolate, aspartame, natural and artificial orange flavor, artificial cream flavor, and alcohol anhydrous; the alcohol is predominantly removed during the manufacturing process.

ALLEGRA (fexofenadine hcl) oral suspension, a white uniform suspension, contains 6 mg ALLEGRA (fexofenadine hydrochloride) per mL and the following excipients: propylene glycol, edetate disodium, propylparaben, butylparaben, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, artificial raspberry cream flavor, sucrose, xylitol and purified water.

OVERDOSE
Dizziness, drowsiness, and dry mouth have been reported with ALLEGRA (fexofenadine hydrochloride) overdose. Single doses of ALLEGRA (fexofenadine hydrochloride) up to 800 mg (6 healthy subjects at this dose level), and doses up to 690 mg twice daily for 1 month (3 healthy subjects at this dose level) or 240 mg once daily for 1 year (234 healthy subjects at this dose level) were administered without the development of clinically significant adverse events as compared to placebo.

In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Following administration of terfenadine, hemodialysis did not effectively remove fexofenadine, the major active metabolite of terfenadine, from blood (up to 1.7% removed).

No deaths occurred at oral doses of ALLEGRA (fexofenadine hydrochloride) up to 5000 mg/kg in mice (110 times the maximum recommended daily oral dose in adults and children based on mg/m2) and up to 5000 mg/kg in rats (230 times the maximum recommended daily oral dose in adults and 210 times the maximum recommended daily oral dose in children based on mg/m2). Additionally, no clinical signs of toxicity or gross pathological findings were observed. In dogs, no evidence of toxicity was observed at oral doses up to 2000 mg/kg (300 times the maximum recommended daily oral dose in adults and 280 times the maximum recommended daily oral dose in children based on mg/m2).

CONTRAINDICATIONS
ALLEGRA (fexofenadine hcl) tablets, ALLEGRA (fexofenadine hcl) ODT and ALLEGRA (fexofenadine hcl) oral suspension are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of ALLEGRA (fexofenadine hcl) . Rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

Allegra side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Allegra: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Allegra and call your doctor if you have fever, chills, body aches, cough, or other flu symptoms.

Less serious Allegra side effects may include:

• nausea, diarrhea, upset stomach;
• menstrual cramps;
• drowsiness, tired feeling;
• headache; or
• muscle or back pain.

Allegra-D Extended-Release Tablets (12 Hour)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Allegra-D Extended-Release Tablets (12 Hour):

Dizziness; dry mouth; headache; nausea; nervousness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Allegra-D Extended-Release Tablets (12 Hour):

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; chest pain; difficult urination; fast or irregular heartbeat; fever; hallucinations; mental or mood changes; seizures; shaking or tremor; stomach pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.