Actifed Cold and Allergy contains a combination of chlorpheniramine and phenylephrine. Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

Actifed Cold and Allergy is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Actifed Cold and Allergy may also be used for other purposes not listed in this medication guide.

Do not use Actifed Cold and Allergy tablets 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. Dangerous side effects may occur if you take Actifed Cold and Allergy before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use Actifed Cold and Allergy during an asthma attack.

Actifed Cold and Allergy tablets 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 Actifed Cold and Allergy. Older adults may be more likely to have side effects from this medicine. Always ask a doctor before giving cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Contact your doctor if your symptoms do not improve or if they get worse after taking Actifed Cold and Allergy for 7 days.

Use Actifed Cold and Allergy as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Dosage for adults and children 12 years and over: Take one tablet every four hours. Do not take more than six tablets in 24 hours.

Do not use Actifed Cold and Allergy tablets in children under 12 years of age. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water.

Contact your doctor if your symptoms do not improve or if they get worse after taking this medicine for 7 days.

Store Actifed Cold and Allergy at room temperature away from moisture and heat.

Do not use Actifed Cold and Allergy 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. Dangerous side effects may occur if you take Actifed Cold and Allergy before the MAO inhibitor has cleared from your body. Do not use Actifed Cold and Allergy if you are allergic to chlorpheniramine or phenylephrine, or if you have:

• severe or uncontrolled high blood pressure;

• severe coronary artery disease;

• narrow angle glaucoma;

• a stomach ulcer; or

• if you are unable to urinate.

Do not use Actifed Cold and Allergy tablets during an asthma attack.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take Actifed Cold and Allergy, tell your doctor if you have:

• kidney disease;
• liver disease;

• diabetes;

• glaucoma;

• circulation problems;

• heart disease or high blood pressure;

• overactive thyroid;

• a seizure disorder such as epilepsy;

• asthma, emphysema or chronic bronchitis; or

• urination problems or an enlarged prostate.

FDA pregnancy category C. It is not known whether Actifed Cold and Allergy is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether chlorpheniramine and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use Actifed Cold and Allergy without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

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 the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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

Overdose can cause nausea, vomiting, diarrhea, stomach pain, problems with balance or coordination, headache, urination problems, dizziness, feeling excited or irritable, hallucinations (seeing things), metallic taste in your mouth, tremors, fever, flushed face, and seizure (convulsions).

Actifed Cold and Allergy 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 Actifed Cold and Allergy.

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

Avoid using other medicines that may cause restlessness (such as caffeine, stimulants, diet pills, and decongestants contained in over-the-counter cold medicines). They can add to the stimulant effects of phenylephrine.

Get emergency medical help if you have any of these signs of an allergic reaction to Actifed Cold and Allergy tablets: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Actifed Cold and Allergy tablets and call your doctor at once if you have any of these serious side effects:

• fast or uneven heart beats;

• feeling light-headed, fainting;

• seizure (convulsions);

• hallucinations (seeing things that are not there); or

• tremors.

Less serious Actifed Cold and Allergy side effects may include:

• heartburn, nausea, vomiting, diarrhea, loss of appetite;

• dry nose or mouth;

• drowsiness, dizziness, weakness, headache;

• dry eyes, blurred vision;

• painful or difficult urination;

• sleep problems (insomnia);

• feeling nervous or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

• mecamylamine (Inversine);

• methyldopa (Aldomet);

• reserpine;

• a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren);

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

• antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and there may be other drugs that can interact with Actifed Cold and Allergy. 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.