Dextromethorphan/acetaminophen/antihistamine - oral
Nite-Time Cold-Flu 6.25 mg-15 mg-325 mg capsule
One ingredient in this product is acetaminophen. Taking too much acetaminophen may cause serious (possibly fatal) liver disease. Adults should not take more than 4000 milligrams (4 grams) of acetaminophen a day. People with liver problems and children should take less acetaminophen. Ask your doctor or pharmacist how much acetaminophen is safe to take.
Do not use with any other drug containing acetaminophen without asking your doctor or pharmacist first. Acetaminophen is in many nonprescription and prescription medications (such as pain/fever drugs or cough-and-cold products). Check the labels on all your medicines to see if they contain acetaminophen, and ask your pharmacist if you are unsure.
Get medical help right away if you take too much acetaminophen (overdose), even if you feel well. Overdose symptoms may include nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, yellowing eyes/skin, and dark urine.
Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol
This combination medication is used to temporarily treat symptoms caused by the common cold, flu, allergies, or other breathing illnesses (such as sinusitis, bronchitis). Dextromethorphan is a cough suppressant that affects a certain part of the brain, reducing the urge to cough. Acetaminophen (APAP) is a non-aspirin pain reliever and fever reducer. Antihistamines help relieve watery eyes, itchy eyes/nose/throat, runny nose, and sneezing.
This medication is not usually used for ongoing coughs from smoking, asthma, or other long-term breathing problems (such as emphysema), or for coughs with a lot of mucus, unless directed by your doctor.
Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.
These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).
See also Warning section.
Read and follow all directions on the package label. Do not give children medicines labeled only for adults. If you have any questions, consult your pharmacist.
Take this medication by mouth with or without food, usually every 4 to 6 hours as needed or as directed by your doctor. If stomach upset occurs, it may help to take this medication with food or milk. Drink plenty of fluids when you use this medication unless otherwise directed by your doctor. The fluid will help loosen the mucus in your lungs.
If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If your liquid form is a suspension, shake the bottle well before each dose.
The dosage is based on your age, medical condition, and response to treatment. Do not increase your dose, take it more frequently, or use it for a longer time than directed. Improper use (abuse) of this medication may result in serious harm (including brain damage, seizure, death).
Tell your doctor if your condition persists for more than 1 week, if it worsens, or if it occurs with rash, persistent headache, or fever lasting more than 3 days. These may be symptoms of a serious medical problem and should be checked by a doctor.
See also Warning section.
Drowsiness, dizziness, blurred vision, upset stomach, nausea, constipation, or dry mouth/nose/throat may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Tell your doctor right away if any of these unlikely but serious side effects occur:
- mental/mood changes (such as confusion, hallucinations)
- trouble urinating
Tell your doctor right away if any of these rare but serious side effects occur:
- fast/irregular heartbeat
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:
- itching/swelling (especially of the face/tongue/throat)
- severe dizziness
- trouble breathing
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Warning section.
Before taking this product, tell your doctor or pharmacist if you are allergic to any of its ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
If you have any of the following health problems, consult your doctor or pharmacist before using this medication:
- breathing problems (such as asthma, emphysema)
- heart problems
- high blood pressure
- kidney problems
- liver disease
- stomach/intestinal problems (such as blockage, constipation, ulcers)
- overactive thyroid (hyperthyroidism)
- urination problems (such as trouble urinating due to enlarged prostate, urinary retention)
This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Some brands of this product may contain sugar, alcohol, or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.
Before having surgery, tell your doctor or dentist that you are taking this medication.
Children may be more sensitive to the effects of this drug. In young children, antihistamines may cause agitation/excitement instead of drowsiness.
Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, constipation, trouble urinating, or mental/mood changes. Dizziness, drowsiness, and confusion can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication may pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug are:
- antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray)
Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, diphenhydramine).
The ingredients in this product are available in many prescription and nonprescription products. Check the labels on all your medicines (such as pain/fever drugs, diet aids, or cough-and-cold/allergy products) because they may contain the same or similar ingredients. Using these drugs along with this product could increase side effects. Ask your pharmacist about using those products safely.
This medication may interfere with certain lab tests (such as urine drug screening tests, urine 5-HIAA), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, extreme tiredness, agitation, confusion, flushing, hallucinations, yellowing eyes/skin, dark urine, seizures. In children, excitement may occur first, and may be followed by: loss of coordination, drowsiness, loss of consciousness, seizures.
Keep all regular medical and laboratory appointments.
Do not take this product for several days before allergy testing because test results can be affected.
If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Information last revised October 2018.
Copyright(c) 2018 First Databank, Inc.
Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.
The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.