Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine (a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin)
Brand names: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Multi-Symptom Nighttime, NyCair, Nyquil Cold Medicine, NyQuil D, Nyquil Liquicap, Robitussin Night Cold, Theraflu Nighttime Severe Cold (pseudoephedrine), Nyquil Hot Therapy, All-Nite Cold, Tylenol Flu Night Time, Tylenol Severe Cold & Flu Night Time, Night Time
What is acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine?
Acetaminophen is a pain reliever and fever reducer.
Doxylamine is an antihistamine that reduces the effects of 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, dextromethorphan, doxylamine, and pseudoephedrine is used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.
This medicine will not treat a cough that is caused by smoking, asthma, or emphysema.
Acetaminophen, dextromethorphan, doxylamine, 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 medicine?
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. You should not use this medicine 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. Avoid drinking alcohol. It may increase your risk of liver damage while you are taking acetaminophen, and can increase certain side effects of doxylamine. 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.
What should I discuss with my healthcare provider before taking this medicine?
You should not use this medicine 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.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
a blockage in your digestive tract (stomach or intestines);
kidney disease;
cough with mucus, or cough caused by emphysema or chronic bronchitis;
enlarged prostate or urination problems; or
if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).
It is not known whether acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine may pass into breast milk and may harm a nursing baby. Antihistamines and decongestans may also slow breast milk production. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.
How should I take this medicine?
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. This 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. 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.
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.
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 this medicine within the past few days. Store at room temperature away from moisture and heat. Do not allow liquid medicine to freeze.
See also: Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine dosage (in more detail)
What happens if I miss a dose?
Since this 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.
Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.
What should I avoid while taking this medicine?
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 you are taking acetaminophen, and can increase certain side effects of doxylamine. 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 medicine side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult 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:
chest pain, rapid pulse;
fast, slow, or uneven heart rate;
severe dizziness or anxiety, feeling like you might pass out;
severe headache;
mood changes, confusion, hallucinations, severe nervousness;
tremor, seizure (convulsions);
fever, easy bruising or bleeding, unusual weakness;
urinating less than usual or not at all;
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, uneven heartbeats, seizure).
Less serious side effects may include:
dizziness, drowsiness, mild headache;
dry mouth, nose, or throat;
constipation, diarrhea, mild nausea, upset stomach;
blurred vision;
feeling 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.
Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Dosing Information
Usual Adult Dose for Cold Symptoms:
acetaminophen/dextromethorphan/doxylamine/PSE 325 mg-15 mg-6.25 mg-30 mg oral capsule: 1 to 2 capsules orally every 6 hours not to exceed 8 capsules daily.
Usual Pediatric Dose for Cold Symptoms:
acetaminophen/dextromethorphan/doxylamine/PSE 325 mg-15 mg-6.25 mg-30 mg oral capsule:
12 yrs and older: 1 to 2 capsules orally every 6 hours not to exceed 8 capsules daily.
What other drugs will affect this medicine?
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 doxylamine.
Ask a doctor or pharmacist if it is safe for you to use acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine if you are also using any of the following drugs:
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 there may be other drugs that can affect acetaminophen, dextromethorphan, doxylamine, 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.
More acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine resources
- Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Side Effects (in more detail)
- Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Dosage
- Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Use in Pregnancy & Breastfeeding
- Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Drug Interactions
- Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine Support Group
- 3 Reviews for Acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine - Add your own review/rating
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Where can I get more information?
- Your pharmacist can provide more information about acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine .
See also: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine side effects (in more detail)
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