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, Children's Tylenol Flu, 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, Triaminic Flu, Cough & Fever, Vicks 44 Cold, Flu and Cough, Vicks Formula 44M
What is Theraflu Severe Cold & Congestion (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 signals in the brain that trigger cough reflex.
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 headache, fever, body aches, runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.
Dextromethorphan will not treat a cough that is caused by smoking.
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 this medication?
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. 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. Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose.
What should I discuss with my healthcare provider before taking this medication?
Do not take this medication without a doctor's advice if you have ever had alcoholic liver disease (cirrhosis) or if you drink more than 3 alcoholic beverages per day. You may not be able to take medicine that contains acetaminophen. Do not use cold medicine if you have untreated or uncontrolled diseases such as glaucoma, asthma, emphysema, chronic bronchitis, high blood pressure, heart disease, coronary artery disease, or overactive thyroid. 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 a cold 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.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
liver disease, cirrhosis, or a history of alcoholism;
a blockage in your digestive tract (stomach or intestines);
diabetes;
kidney disease;
epilepsy or other seizure disorder;
cough with mucus, or cough caused by emphysema or chronic bronchitis;
enlarged prostate or urination problems;
pheochromocytoma (an adrenal gland tumor); or
if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).
It is not known whether acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine will harm an unborn baby. Do not use cold medicine without medical advice if you are pregnant. This medication may pass into breast milk and may harm a nursing baby. Do not use cold medicine without medical advice if you are breast-feeding a baby.
How should I take Theraflu Severe Cold & Congestion (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. Cold medicine is usually taken only for a short time until your symptoms clear up.
Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death.
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.
The chewable tablet must be chewed thoroughly before you swallow it.
Dissolve one packet of the powder in at least 4 ounces of water. Stir this mixture and drink all of it right away.
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.
Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.
If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.
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?
Seek emergency medical attention or call the Poison Help line at 1 800 222 1222. An overdose of acetaminophen can be fatal.
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.
What should I avoid while taking this medication?
Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen. This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
This medication 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 a serious side effect such as:
fast or pounding heartbeats, severe restless feeling or nervousness;
mood changes, confusion, hallucinations, unusual thoughts or behavior;
tremor, seizure (convulsions);
easy bruising or bleeding, unusual weakness;
urinating less than usual or not at all;
feeling short of breath;
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
dizziness, drowsiness;
dry mouth, nose, or throat;
constipation or diarrhea;
blurred vision; or
feeling nervous or restless.
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 Theraflu Severe Cold & Congestion (acetaminophen, chlorpheniramine, dextromethorphan, and pseudoephedrine)?
Ask a doctor or pharmacist before using this medicine if you regularly use other medicines that make you sleepy (such as narcotic pain medication, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by chlorpheniramine.
Tell your doctor about all other medicines you use, especially:
leflunomide (Arava);
topiramate (Topamax);
zonisamide (Zonegran);
an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;
an antidepressant;
birth control pills or hormone replacement therapy;
bladder or urinary medications;
blood pressure medication;
a bronchodilator;
cancer medicine;
cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;
gout or arthritis medications (including gold injections);
HIV/AIDS medication;
medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;
medicines to treat psychiatric disorders;
an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or
seizure medication.
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 Theraflu Severe Cold & Congestion resources
- Theraflu Severe Cold & Congestion Side Effects (in more detail)
- Theraflu Severe Cold & Congestion Use in Pregnancy & Breastfeeding
- Theraflu Severe Cold & Congestion Drug Interactions
- Theraflu Severe Cold & Congestion Support Group
- 1 Review for Theraflu Severe Cold & Congestion - Add your own review/rating
- Vicks Formula 44M Liquid MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Theraflu Severe Cold & Congestion 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: Theraflu Severe Cold & Congestion side effects (in more detail)
