In the U.S.—

• Antihistamine (H₁-receptor)–decongestant

Fexofenadine (fex-oh-FEN-a-deen) is an antihistamine and pseudoephedrine (soo-doe-e-FED-rin ) is a decongestant. The combination of these two medicines is used to treat the nasal congestion (stuffy nose), sneezing, and runny nose caused by hay fever.

ALLEGRA is available only with your doctor's prescription, in the following dosage forms:

Oral
• Extended-release tablets [12 hour] (U.S.)
• Extended-release tablets [24 hour] (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fexofenadine and pseudoephedrine combination, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fexofenadine or pseudoephedrine, or to amphetamine, dextroamphetamine (e.g., Dexedrine), ephedrine (e.g., Ephed II), epinephrine (e.g., Adrenalin), isoproterenol (e.g., Isuprel), metaproterenol (e.g., Alupent), methamphetamine (e.g., Desoxyn), norepinephrine (e.g., Levophed), phenylephrine (e.g., Neo-Synephrine), phenylpropanolamine (e.g., Dexatrim), or terbutaline (e.g., Brethine). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—In animal studies, ALLEGRA did not cause birth defects but did cause a decrease in weight of newborn and bone formation in the ribs. Discuss with your doctor whether or not you should continue to use ALLEGRA if you become pregnant.

Breast-feeding—It is not known whether fexofenadine passes into breast milk, but pseudoephedrine does pass into breast milk. Discuss with your doctor the risks of breast-feeding while taking ALLEGRA.

Children—Use is not recommended in infants and children up to 12 years of age. In children 12 years of age and older, ALLEGRA is not expected to cause different side effects or problems than it does in adults.

Older adults—Some side effects may be more likely to occur in elderly patients, who are usually more sensitive to the effects of ALLEGRA.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ALLEGRA, it is especially important that your health care professional know if you are taking any of the following:

• Antacids that contain magnesium or aluminum (e.g., Maalox)—May decrease the amount of fexofenadine in your body. This medication should not be taken closely in time with antacids containing magnesium or aluminum.

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—If you are now taking, or have taken within the past 2 weeks, any of the MAO inhibitors, the side effects of pseudoephedrine may become more severe; these medicines should not be used together

• Diabetes mellitus (sugar diabetes)—Use of ALLEGRA may cause an increase in blood glucose levels

• Enlarged prostate or
• Urinary tract blockage or difficult urination—Use of ALLEGRA may cause urination to be more difficult. You should not take ALLEGRA if you have these conditions.

• Glaucoma or
• Increased pressure in the eye—Use of ALLEGRA may make the condition worse. You should not take ALLEGRA if you have these conditions.

• Heart or blood vessel disease or
• High blood pressure—Use of ALLEGRA may make the condition worse. You should not take ALLEGRA if you have high blood pressure, especially if it is severe.

• Kidney disease—Effects may be increased because of slower removal of the medicine from the body. The 24-hour extended-release tablet should not be used if you have kidney problems.

• Overactive thyroid—Serious effects on the heart may occur

Swallow the extended-release tablet whole. Do not crush, break, or chew it before swallowing.

ALLEGRA is best taken on an empty stomach (either one hour before or two hours after a meal).

ALLEGRA should be taken with water. Do not take with fruit juices or antacids.

Dosing—

The dose of ALLEGRA may be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ALLEGRA. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (extended-release tablets [12 hour]):
  • For symptoms of hay fever:
    • Adults and teenagers—1 tablet two times a day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (extended-release tablets [24 hour]):
  • For symptoms of hay fever:
    • Adults and teenagers—1 tablet one time a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of ALLEGRA, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store ALLEGRA:

• Keep out of the reach of children.
• Store away from heat and direct light in a tightly closed container.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.