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, Comtrex Cold and Flu Maximum Strength Tablet, 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
What is acetaminophen, chlorpheniramine, dextromethorphan 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.
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 not 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 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 or pharmacist before using any other cough, cold, allergy, or sleep medication. Acetaminophen (sometimes abbreviated as "APAP"), chlorpheniramine, dextromethorphan, or pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. 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.
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 if it is safe for you to take this medicine if you have:
liver or kidney disease;
alcoholism or cirrhosis of the liver;
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
glaucoma; or
an enlarged prostate or problems with urination.
FDA pregnancy category C. It is not known whether this medication will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. 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 cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.
How should I take acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine?
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. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.
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. Drink extra fluids while you are taking acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine. 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.
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.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with 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 surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
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?
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 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?
Ask a doctor or pharmacist before using any other cough, cold, allergy, or sleep medication. Acetaminophen (sometimes abbreviated as "APAP"), chlorpheniramine, dextromethorphan, or 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, an antihistamine, or a decongestant. Avoid drinking alcohol. It may increase your risk of liver damage. 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 effects
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 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);
dizziness, drowsiness;
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.
Tell your doctor about all other medicines you use, especially:
celecoxib (Celebrex);
cinacalcet (Sensipar);
darifenacin (Enablex);
imatinib (Gleevec);
isoniazid;
quinidine (Quinaglute, Quinidex);
ranolazine (Ranexa)
ritonavir (Norvir);
sibutramine (Meridia);
terbinafine (Lamisil);
zidovudine (Retrovir, AZT);
an antidepressant;
a bronchodilator;
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 other drugs may interact with acetaminophen, chlorpheniramine, dextromethorphan 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.
More Tylenol Cold and Cough resources
- Tylenol Cold and Cough Side Effects (in more detail)
- Tylenol Cold and Cough Use in Pregnancy & Breastfeeding
- Drug Images
- Tylenol Cold and Cough Drug Interactions
- Tylenol Cold and Cough Support Group
- 1 Review for Tylenol Cold and Cough - Add your own review/rating
- Vicks Formula 44M Liquid MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Tylenol Cold and Cough with other medications
- Cold Symptoms
- Influenza
Where can I get more information?
- Your pharmacist can provide more information about acetaminophen, chlorpheniramine, dextromethorphan and pseudoephedrine.
See also: Tylenol Cold and Cough side effects (in more detail)
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