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Medications and Drugs

Brand Names: Alka-Seltzer Plus Cold Formula

Generic Name: aspirin, chlorpheniramine, and phenylephrine (Pronunciation: ASP rin, KLOR fen IR a meen, and FEN il EFF rin)

What is aspirin, chlorpheniramine, and phenylephrine (Alka-Seltzer Plus Cold Formula)?

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).

The combination of aspirin, chlorpheniramine, and phenylephrine is 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.

Aspirin, chlorpheniramine, and phenylephrine may also be used for purposes not listed in this medication guide.

What are the possible side effects of this medicine (Alka-Seltzer Plus Cold Formula)?

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.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • fast, slow, or uneven heart rate, tremor, seizure (convulsions);
  • ringing in your ears, severe headache, mood changes, severe dizziness or anxiety, hallucinations, feeling like you might pass out;
  • redness or swelling, new cold or flu symptoms;
  • feeling short of breath, urinating less than usual or not at all; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, uneven heartbeats, seizure).

Less serious side effects may include:

  • mild headache, mild dizziness, drowsiness;
  • 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.

What is the most important information I should know about this medicine (Alka-Seltzer Plus Cold Formula)?

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.

You should not use this medication if you have severe constipation, a blockage in your stomach or intestines, or if you are unable to urinate.

Do not use this medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma or COPD, high blood pressure, heart disease, coronary artery disease, or overactive thyroid.

Do not use this medicine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

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.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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