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|Fexofenadine/Pseudoephedrine Extended-Release Tablets

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Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour)

Generic Name: Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) (FEX-oh-FEN-a-deen/SOO-doe-e-FED-rin)
Brand Name: Allegra-D 24 Hour

Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) is used for:

Relieving seasonal allergy symptoms, including sneezing, runny nose, itchy nose/palate/throat, itchy/watery/red eyes, and nasal congestion.

Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) is an antihistamine and decongestant combination. The antihistamine works by blocking the effects of histamine, which cause allergy symptoms such as sneezing, runny nose, and itchy/watery eyes. The decongestant works by stimulating the body"s natural response and reducing the swelling in the blood vessels that supply the mucous membrane, thereby decreasing nasal congestion.

Do NOT use Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) if:

you are allergic to any ingredient in Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour)
you have severe heart/blood vessel disease or severe high blood pressure
you have narrow-angle glaucoma, kidney failure, or are unable to urinate (eg, urinary retention)
you have had side effects from previous decongestant use (eg, trouble sleeping, involuntary trembling, irregular heart rhythm)
you are taking droxidopa, furazolidone, or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken an MAOI within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour):

Some medical conditions may interact with Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour). Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have diabetes, overactive thyroid, kidney problems, enlarged prostate, seizure disorders (eg, epilepsy), high blood pressure, heart problems, or glaucoma or increased pressure in the eye
if you take medicine for high blood pressure

Some MEDICINES MAY INTERACT with Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour). Tell your health care provider if you are taking any other medicines, especially any of the following:

Digoxin or droxidopa because the risk of irregular heartbeat may be increased
Furazolidone, ketoconazole, MAOIs (eg, phenelzine), methyldopa, or urinary alkalinizers (eg, potassium citrate) because they may increased the risk of Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour)"s side effects
Bromocriptine because the risk of its side effects may be increased by Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour)
Guanadrel, guanethidine, mecamylamine, reserpine, or other medicine for high blood pressure because their effectiveness may be decreased by Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour)

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour):

Use Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
Swallow Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) whole. Do not break, crush, or chew before swallowing.
Take Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) with a full glass of water (8 oz/240 mL).
Do not drink fruit juice at the same time that you take Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour). Certain fruit juices (eg, grapefruit, apple, orange) may decrease Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour)"s effectiveness.
If you take antacids that contain aluminum or magnesium, do not take them at the same time as Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour). Ask your doctor or pharmacist how to take them with Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour).
Do not take more of Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) than recommended by your doctor.
If you miss a dose of Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour), take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour).

Important safety information:

Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) may cause dizziness. It does not usually cause drowsiness when used under normal circumstances at the recommended doses. However, these effects may be worse if you take it with alcohol or certain medicines. Use Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
You may occasionally notice the tablet shell in your stool. This is normal and not a cause for concern.
Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) for a few days before the tests.
Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) has an antihistamine and decongestant in it. Before you start any new medicine, check the label to see if it has an antihistamine or decongestant in it too. If it does or if you are not sure, check with your doctor pharmacist.
Diabetes patients - Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Use Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) with caution in the ELDERLY; they may be more sensitive to its effects.
Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) while you are pregnant. It is not known if Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) is found in breast milk. If you are or will be breast-feeding while you use Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour), check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 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:

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

Seek medical attention right away if any of these SEVERE side effects occur:

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

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest pain; difficulty breathing; drowsiness; fast or irregular heartbeat; loss of consciousness; seizures; severe or persistent dizziness or headache; unusual nervousness or excitement.

Proper storage of Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour):

Store Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) out of the reach of children and away from pets.

General information:

If you have any questions about Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour), please talk with your doctor, pharmacist, or other health care provider.
Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour) is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fexofenadine/Pseudoephedrine Extended-Release Tablets (24 Hour). If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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