Allegra ODT

Since cold or allergy medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by fexofenadine.

Tell your doctor about all other medicines you use, especially:

• ketoconazole (Nizoral); or

• erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole).

This list is not complete and other drugs may interact with fexofenadine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

In the U.S.

• Allegra
• Allegra ODT

Available Dosage Forms:

• Tablet
• Tablet, Disintegrating
• Capsule
• Suspension

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Butyrophenone

This section provides information on the proper use of a number of products that contain fexofenadine. It may not be specific to Allegra ODT. Please read with care.

You should always take this medicine with water. Do not take it with juice such as grapefruit, orange, or apple juice .

You should NOT take antacids that contain aluminum or magnesium hydroxide within 15 minutes of taking this medicine. If you are uncertain about this, ask your doctor or pharmacist .

For patients using the oral disintegrating tablet form of this medicine:

• Make sure your hands are dry.
• Do not push the tablet through the foil backing of the package. Instead, gently peel back the foil backing and remove the tablet.
• Immediately place the tablet on top of the tongue. Do not chew or break the tablet.
• The tablet will dissolve in seconds, and you may swallow it with your saliva. You may drink a glass of water after the tablet has dissolved.
• Always take this tablet on an empty stomach .

Shake the oral liquid well before using it. Measure the liquid with a marked measuring spoon, oral syringe, or medicine cup .

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 symptoms of hay fever:
  • For oral dosage form (capsules, tablets):
    • Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
    • Children 6 to 11 years of age—30 mg two times a day.
    • Children 4 to 6 years of age—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 (disintegrating tablets):
    • Children 6 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
    • Children 4 to 6 years of age—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 (suspension):
    • Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor .

• For symptoms of chronic hives:
  • For oral dosage form (capsules, tablets):
    • Adults and children 12 years of age and older—60 milligrams (mg) two times a day, or 180 mg once a day.
    • Children 4 to 11 years of age—30 mg two times a day.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor .
  • For oral dosage form (disintegrating tablets):
    • Children 4 to 11 years of age—30 milligrams (mg) two times a day, on an empty stomach.
    • Children younger than 4 years of age—Use and dose must be determined by your doctor .
  • For oral dosage form (suspension):
    • Children 4 to 11 years of age—30 milligrams (mg) or 5 milliliters (mL) two times a day.
    • Children 6 months to 4 years of age—15 mg or 2.5 mL two times a day.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor .

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• It is used to ease allergy signs.
• It is used to treat hives.

Use Allegra ODT as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Avoid taking this medicine with fruit juice.
• Do not take antacids that have magnesium or aluminum at the same time as Allegra ODT. Talk with your doctor or pharmacist.
• Take on an empty stomach. Take 1 hour before or 2 hours after meals.
• Do not take this medicine out of the blister pack until you are ready to take it. Take Allegra ODT right away after opening the blister pack. Do not store the removed drug for future use.
• Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your tongue and let it melt. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
• If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.

What do I do if I miss a dose?

• If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Allegra ODT is taken on an as needed basis. Do not take more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Allegra ODT (fexofenadine orally disintegrating tablets) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Allegra ODT. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Applies to fexofenadine: oral capsule, oral suspension, oral tablet, oral tablet disintegrating

Along with its needed effects, fexofenadine (the active ingredient contained in Allegra ODT) 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 immediately if any of the following side effects occur while taking fexofenadine:

• Chest tightness
• feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• shortness of breath, difficult or labored breathing

Some side effects of fexofenadine 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:

• Vomiting

• Back pain
• body aches or pain
• chills
• coughing
• diarrhea
• difficulty with moving
• dizziness
• ear congestion
• earache
• fever
• headache
• joint pain
• loss of voice
• muscle aching or cramping
• muscle pains or stiffness
• nasal congestion
• nausea
• pain in arms or legs
• pain or tenderness around eyes or cheekbones
• painful menstrual bleeding
• redness or swelling in ear
• ringing or buzzing in ears
• runny or stuffy nose
• sleepiness or unusual drowsiness
• sneezing
• sore throat
• stomach upset
• swollen joints
• unusual feeling of tiredness or weakness
• viral infection (such as cold and flu)

• Nervousness
• rash
• sleeplessness
• terrifying dreams
• trouble sleeping