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acetaminophen, chlorpheniramine, and pseudoephedrine
Pronunciation: a seet a MIN oh fen, klor fen IR a meen, soo doe e FED rin
Brand: Alka-Seltzer Plus Cold Liquigel, Allerest Headache Strength, Allerest Sinus, Cold Medicine Plus, Comtrex Allergy Sinus, Comtrex Allergy Sinus Maximum Strength, Comtrex Allergy Sinus Night and Day, Kolephrin, Sinarest, Sinutab Ex-Strength, Theraflu Cold & Sore Throat (pseudoephedrine), Theraflu Flu & Sore Throat (pseudoephedrine), Theraflu Maximum Strength, Tylenol Allergy Sinus Gelcap


What is the most important information I should know about acetaminophen, chlorpheniramine, and pseudoephedrine?
• There are many brands and forms of this medication available and not all brands are listed on this leaflet.
nochild• 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.
donot• Do not use this medication 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.
emt• An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, you should never use more than 2 grams (2000 mg) of acetaminophen per day.
noalcohol• Drinking alcohol may increase your risk of liver damage. Ask a doctor or pharmacist if it is safe for you to take this medicine if you have liver disease or a history of alcoholism.


What is acetaminophen, chlorpheniramine, and pseudoephedrine?
• Acetaminophen is a pain reliever and fever reducer.
• 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.
• Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
• The combination of acetaminophen, chlorpheniramine, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, sneezing, and pain or fever caused by allergies or the common cold.
• Acetaminophen, chlorpheniramine, and pseudoephedrine may also be used for purposes not listed in this medication guide.


What should I discuss with my healthcare provider before taking acetaminophen, chlorpheniramine, and pseudoephedrine?
donot• Do not use this medication 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.
donot• Do not take this medication if you are allergic to acetaminophen, chlorpheniramine, or pseudoephedrine.
• Tell your doctor if you drink more than 3 alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.
• Ask a doctor or pharmacist if it is safe for you to take acetaminophen, chlorpheniramine, and pseudoephedrine if you have:
     · heart disease, high blood pressure;
     · liver disease, a history of alcoholism, or cirrhosis of the liver;
     · glaucoma;
     · kidney disease;
     · diabetes;
     · a thyroid disorder;
     · an enlarged prostate; or
     · problems with urination.
nopreg• This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
nobrfeed• This medication may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
• Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.


How should I take acetaminophen, chlorpheniramine, and pseudoephedrine?
• Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine should be taken only for a short time until your symptoms clear up.
donot• An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. Ask a doctor before taking acetaminophen if you drink more than 3 alcoholic beverages per day, and never take more than 2 grams (2000 mg) of acetaminophen per day.
nochild• Do not give this medication to a child younger than 2 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.
food• Take this medication with food or milk if it upsets your stomach.
• Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
donot• 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.
• 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.
• 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.
rt• Store this medication at room temperature, away from heat, light, and moisture.


What happens if I miss a dose?
• Since cold medicine is taken when 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
emt• Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
• The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
• Overdose symptoms may also include extreme drowsiness, warmth or tingly feeling, or seizure (convulsions).


What should I avoid while taking acetaminophen, chlorpheniramine, and pseudoephedrine?
dizzy• This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
noalcohol• Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor's advice, and never take more than 2 grams (2000 mg) per day.
donot• Ask a doctor or pharmacist before using any other cold, allergy, or pain medication. Acetaminophen (sometimes abbreviated as "APAP"), chlorpheniramine, and pseudoephedrine 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 acetaminophen, APAP, chlorpheniramine, or 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.
• Avoid becoming overheated or dehydrated during exercise and in hot weather.


What are the possible side effects of acetaminophen, chlorpheniramine, and pseudoephedrine?
emt• 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.
donot• Stop using this medication and call your doctor at once if you have a serious side effect such as:
     · fast or pounding heartbeats;
     · severe dizziness or nervousness, confusion, hallucinations, unusual thoughts or behavior;
     · severe dizziness, anxiety, restless feeling, or nervousness;
     · dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).
     · urinating less than usual or not at all;
     · easy bruising or bleeding, unusual weakness; or
     · nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
• Less serious side effects may include:
     · blurred vision;
     · dry mouth;
     · upset stomach, constipation;
     · dizziness or drowsiness, problems with memory or concentration;
     · mild loss of appetite;
     · ringing in your ears;
     · sleep problems (insomnia);
     · skin rash, redness, or itching; or
     · problems with memory or concentration;
     · feeling restless or excited (especially in children).
     · warmth, tingling, or redness under your skin.
• 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 other drugs will affect acetaminophen, chlorpheniramine, and pseudoephedrine?
dizzy• Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.
• Also tell your doctor if you are using any of the following drugs:
     · an antidepressant;
     · a bronchodilator;
     · a diuretic (water pill);
     · gout medications;
     · blood pressure medication;
     · medication to treat irritable bowel syndrome;
     · bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
     · seizure medication;
     · isoniazid;
     · zidovudine (Retrovir, AZT);
     · aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others); or
     · a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.
• This list is not complete and other drugs may interact with acetaminophen, chlorpheniramine, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.


Where can I get more information?
• Your pharmacist can provide more information about acetaminophen, chlorpheniramine, and pseudoephedrine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2011 Cerner Multum, Inc. Version: 9.01. Revision Date: 1/12/2011.