Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Chlorpheniramine is an antihistamine that reduces the effects of 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).

Alka-Seltzer Plus Cold Formula is a combination medicine used to treat fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

Alka-Seltzer Plus Cold Formula may also be used for purposes not listed in this medication guide.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not give this medication to a child younger than 4 years old. 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.

Aspirin may cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking this medication, especially in older adults. Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. This medicine is usually taken only for a short time until your symptoms clear up.

Drop the effervescent tablets into a glass of water (at least 4 ounces, or one-half cup). Stir this mixture and drink all of it right away.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a sore throat that lasts longer than 2 days, or a fever with a headache, cough, or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken this medicine within the past few days.

Store at room temperature away from moisture and heat.

You should not use this medication if you are allergic to aspirin, chlorpheniramine, or phenylephrine.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Aspirin may cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking aspirin, especially in older adults.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not give this medication to a child younger than 4 years old. 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.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:

• asthma or COPD, cough with mucus, or cough caused by smoking, emphysema, or chronic bronchitis;

• heartburn, stomach pain, indigestion, ulcer, or a blockage in your stomach or intestines;

• kidney or liver disease;

• high blood pressure, heart disease, coronary artery disease, or recent heart attack;

• enlarged prostate or urination problems;

• glaucoma;

• diabetes;

• epilepsy or other seizure disorder;

• pheochromocytoma (an adrenal gland tumor);

• overactive thyroid;

• if you are on a low-salt diet; or

• if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).

FDA pregnancy category C. Aspirin may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Do not use this medicine without medical advice if you are pregnant.

It is not known whether Alka-Seltzer Plus Cold Formula passes into breast milk or if it could harm a nursing baby. Antihistamines and decongestants may also slow breast milk production. Do not use this medicine without medical advice if you are breast-feeding a baby.

Since Alka-Seltzer Plus Cold Formula is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Drinking alcohol can increase certain side effects of this medication. Alcohol may also increase your risk of stomach bleeding while you are taking aspirin.

Ask a doctor or pharmacist before using any other cold, allergy, cough, or sleep medicine. Aspirin (sometimes abbreviated as ASA), antihistamines, and decongestants are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an aspirin, ASA, an antihistamine, or a decongestant.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medicine may cause serious side effects. Stop using this medicine and call your doctor at once if you have:

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• chest pain, rapid pulse, fast or uneven heart rate;

• ringing in your ears, severe headache, confusion, hallucinations, severe nervousness, feeling like you might pass out;

• tremor, seizure (convulsions);

• feeling short of breath, little or no urinating;

• redness or swelling, new cold or flu symptoms;

• easy bruising or bleeding, unusual weakness; or

• dangerously high blood pressure (severe headache, buzzing in your ears, anxiety, shortness of breath).

Common side effects of Alka-Seltzer Plus Cold Formula may include:

• dizziness, drowsiness, blurred vision;

• dry mouth, nose, or throat;

• heartburn, nausea, diarrhea, constipation, upset stomach;

• feeling nervous, restless, or irritable; or

• sleep problems (insomnia).

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.

Ask your doctor before using Alka-Seltzer Plus Cold Formula if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with aspirin may cause you to bruise or bleed easily.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking chlorpheniramine and phenylephrine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with aspirin, chlorpheniramine, and phenylephrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.