Allegra-D

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 .

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.

Pediatric

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 .

Geriatric

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

Pregnancy

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.

Interactions with 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
• 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.

• Eliglustat
• Guanethidine
• Iobenguane I 123
• Methyldopa
• Midodrine
• Simeprevir

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

Interactions with Food/Tobacco/Alcohol

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

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:

• Trouble in sleeping

• Cough
• dizziness
• irregular heartbeat
• nervousness
• sore throat

• 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:

• Headache
• nausea

• Abdominal or stomach pain
• agitation
• anxiety
• back pain
• dry mouth
• heartburn

• 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.

one tablet (60 mg-120 mg) orally twice a day.
or
one tablet (180 mg-240 mg) orally once a day.

13 years or older:
one tablet (60 mg-120 mg) orally twice a day.
or
one tablet (180 mg-240 mg) orally once a day.

CrCl less than 80 mL/min: one tablet (60 mg-120 mg) orally once a day.

The FDA has not approved use of over-the-counter cough and cold medications to children aged less than 2 years, and proper dosing for children in this age group has not been studied. Clinicians should be aware of the risk for serious illness or fatal overdose from administration of cough and cold medications to children aged less than 2 years. Clinicians should be certain that caregivers understand 1) the importance of administering cough and cold medications only as directed and 2) the risk for overdose if they administer additional medications that might contain the same ingredient.