Generic Name: acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine (a SEET a MIN oh fen, KLOR fen EER a meen, DEX troe meth OR fan, SOO doe ee FED rin)Brand Names: Alka-Seltzer Plus Cough and Cold Liquigel, Comtrex Cold and Flu Maximum Strength Liquid, Contac Cold and Flu Maximum Strength, Robitussin Flu, Robitussin Honey Flu Nighttime, Theraflu (pseudoephedrine) Cold & Cough, Theraflu Flu & Cough, Theraflu Night Cough and Cold and Flu, Theraflu Nightime Maximum Strength, Theraflu Severe Cold & Congestion, Triaminic Cold and Fever, Tylenol Cold Complete Formula, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M
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.
Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.
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, dextromethorphan, and pseudoephedrine is used to treat runny or stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.
Acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine may also be used for purposes other than those listed in this medication guide.What is the most important information I should know about acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?Do not take pseudoephedrine 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. Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Do not use any other cough, cold, or allergy 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 acetaminophen (sometimes abbreviated as "APAP"), chlorpheniramine, dextromethorphan, or pseudoephedrine. Do not give this medicine to a child without a doctor's advice. Death can occur from the misuse of cough or cold medicine in very young children. Always ask your doctor before treating a cough or cold in a child.What should I discuss with my healthcare provider before taking acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?Do not use this medication if you are allergic to acetaminophen, chlorpheniramine, dextromethorphan or pseudoephedrine, or to similar medications such as other decongestants, diet pills, stimulants, or ADHD medications. Do not use this medication 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 a cough or cold medicine before the MAO inhibitor has cleared from your body.
Ask a doctor or pharmacist about using acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine if you have:
liver or kidney disease;
alcoholism or cirrhosis of the liver;
heart disease or high blood pressure;
a thyroid disorder;
an enlarged prostate or problems with urination.
Artificially-sweetened liquid forms of cough-and-cold medications 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, dextromethorphan 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. Cough-and-cold medicines should be taken only for a short time until your symptoms clear up.Drink extra fluids while you are taking acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine. An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One packet of the oral powder may contain up to 1000 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. 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.
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.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.Store the medicine at room temperature, away from heat, light, and moisture.
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.
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 dry mouth, feeling restless or nervous, dizziness, drowsiness, diarrhea, loss of appetite, warmth or tingly feeling, seizure (convulsions), or coma.What should I avoid while taking acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?Do not use any other cough, cold, pain, or allergy medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP"), chlorpheniramine, dextromethorphan and pseudoephedrine are contained in many combination medicines. 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 acetaminophen, APAP, chlorpheniramine, dextromethorphan or pseudoephedrine. 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) of acetaminophen per day. 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 becoming overheated or dehydrated during exercise and in hot weather.
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with pseudoephedrine can increase your risk of unpleasant side effects.Acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine side effectsGet 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 medication and call your doctor at once if you have any of these serious side effects:
fast, pounding, or uneven heartbeat;
confusion, hallucinations, unusual thoughts or behavior;
slow, shallow breathing;
severe dizziness, anxiety, restless feeling, or nervousness;
urinating less than usual or not at all;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or
nausea, stomach pain, low fever, 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;
nausea, stomach pain, constipation;
warmth, tingling, or redness under your skin;
restless or excitability (especially in children);
sleep problems (insomnia);
problems with memory or concentration;
ringing in your ears; or
skin rash, redness, or itching.
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, dextromethorphan and pseudoephedrine?Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as 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 or dextromethorphan.
Also tell your doctor if you are using any of the following drugs:
quinidine (Quinaglute, Quinidex);
zidovudine (Retrovir, AZT);
a diuretic (water pill);
medication to treat irritable bowel syndrome, bladder spasms, or urinary incontinence;
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
medicines to treat high blood pressure;
gout medication such as probenecid (Benemid);
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; or
seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton).
This list is not complete and there may be other drugs that can interact with acetaminophen, chlorpheniramine, dextromethorphan 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.