Pronunciation:

fex-oh-FEN-a-deen hye-droe-KLOR-ide, soo-doe-e-FED-rin hye-droe-KLOR-ide

Brand Names:

• Allegra-D
• Allegra-D 24Hour

Dosage Forms:

• Tablet, Extended Release, 24 HR
• Tablet, Extended Release

Classifications:

Therapeutic—

Antihistamine, Less-Sedating/Decongestant Combination

Pharmacologic—

Fexofenadine

Chemical—

Fexofenadine

Uses of This Medicine:

Fexofenadine is an antihistamine and pseudoephedrine 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.

This medicine is available only with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

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

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Older adults—

Some side effects may be more likely to occur in elderly patients, who are usually more sensitive to the effects of this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Levoketoconazole
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adagrasib
• Apomorphine
• Capmatinib
• Epinephrine
• Guanethidine
• Iobenguane I 123
• Iobenguane I 131
• Itraconazole
• Methyldopa
• Midodrine
• Pitolisant
• Simeprevir
• Venetoclax
• Zavegepant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• St John's Wort

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Apple Juice
• Grapefruit Juice
• Orange Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

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

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

• Heart or blood vessel disease or
• High blood pressure—Use of this medicine may make the condition worse. You should not take this medicine 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

Proper Use of This Medicine:

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

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

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

Dosing—

The dose of this medicine will 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (extended-release tablets [12 hour]):
  • For symptoms of hay fever:
    • Adults and teenagers—1 tablet two times a day.
    • Children 4 years of age and older—Use and dose must be determined by your doctor.
    • Children and infants up to 4 years of age—Use is not recommended .
• For oral dosage form (extended-release tablets [24 hour]):
  • For symptoms of hay fever:
    • Adults and teenagers—1 tablet one time a day.
    • Children 4 years of age and older—Use and dose must be determined by your doctor.
    • Children and infants up to 4 years of age—Use is not recommended .

Missed dose—

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

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Trouble in sleeping

Less common

Cough

dizziness

irregular heartbeat

nervousness

sore throat

Incidence not known

Difficult or labored breathing

difficulty swallowing

dizziness

fast heartbeat

feeling of warmth

fever

hives or welts

itching skin

itching, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

reddening of the skin, especially around ears

redness of the face, neck, arms and occasionally, upper chest

shortness of breath

skin rash

tightness in chest

swelling of eyes, face, or inside of nose

unusual tiredness or weakness

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

nausea

Less common

Abdominal or stomach pain

agitation

anxiety

back pain

dry mouth

heartburn

Incidence not known

Terrifying dreams causing sleep disturbances

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.