Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Oral tablet, extended release 12 hour

What is this medicine?

CETIRIZINE; PSEUDOEPHEDRINE (se TI ra zeen; soo doe e FED rin) is an antihistamine and decongestant. This medicine is used to treat or prevent symptoms of allergies. It reduces congestion, sneezing, runny nose, and itching in the nose or throat. It also helps relieve itchy, watery, and red eyes.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• disease of the blood vessels or heart

• difficulty urinating

• glaucoma

• high blood pressure

• kidney disease

• liver disease

• prostate trouble

• untreated thyroid problems

• an unusual or allergic reaction to cetirizine, pseudoephedrine, hydroxyzine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not break, crush, or chew the tablets. Take your doses at regular intervals, no more than every 12 hours. You may take with or without food. Do not take your medicine more often than directed.

Contact your doctor or health care professional regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 12 years of age for selected conditions, precautions do apply.

Patients over 60 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines for colds, breathing difficulties

• medicines for headaches like dihydroergotamine, ergotamine

• procarbazine

• stimulants

This medicine may also interact with the following medications:

• alcohol

• bromocriptine

• caffeine

• linezolid

• medicines for allergies

• medicines for depression like fluoxetine, paroxetine

• medicines for heart disease or blood pressure like atenolol, clonidine, digoxin, doxazosin, mecamylamine, reserpine

• methyldopa

• St. John's wort

• tizanidine

• yohimbine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. Tell your doctor or health care professional if your symptoms do not improve. If you have high blood pressure, check your blood pressure regularly. Ask your health care professional what your blood pressure should be, and when you should contact him or her.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision or hearing

• fast heartbeat or chest pain

• hallucinations

• high blood pressure

• infection

• tremors, muscle contractions

• trouble passing urine or change in the amount of urine

• yellowing of the eyes, skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• dry mouth

• loss of appetite or nausea

• nervousness or difficulty sleeping

• nose bleed

• sore throat

• stomach upset or pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. Throw away any unused medicine after the expiration date.