Acrivastine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of acrivastine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Acrivastine and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken for only a short time until your symptoms clear up.

Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Take this medicine with a full glass of water.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store the medication at room temperature away from moisture and heat.

Before taking this medication, tell your doctor if you are using any of the following drugs:

• medicines to treat high blood pressure;

• a diuretic (water pill);

• methyldopa (Aldomet);

• medication to treat irritable bowel syndrome;

• bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

• aspirin or salicylates (such as Disalcid, Doan’s Pills, Dolobid, Salflex, Tricosal, and others);

• a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

• antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

If you are using any of these drugs, you may not be able to use acrivastine and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect acrivastine and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid using other medicines that make you sleepy (such as sleeping pills, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by acrivastine and pseudoephedrine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor’s advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an overdose may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

Since cold or allergy medicine is usually taken only 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Always ask a doctor before giving a cold or allergy medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Acrivastine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to acrivastine, or pseudoephedrine, or if you have:

• kidney disease;

• glaucoma;

• heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• an enlarged prostate; or

• problems with urination.

If you have any of these conditions, you may not be able to use acrivastine and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Acrivastine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Your pharmacist has information about acrivastine and pseudoephedrine written for health professionals that you may read.

Acrivastine and pseudoephedrine is available with a prescription under the brand name Semprex-D. This medication may be available in other forms. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Semprex-D 8 mg of acrivastine and 60 mg of pseudoephedrine— green/white capsules