ne 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.Who should not take Pain Relief Cold & Cough?
This combination product is used to temporarily treat cough, fever, and other symptoms (e.g., headache, sore throat, body aches) that are caused by the common cold, flu, or other breathing illnesses (e.g., bronchitis). Dextromethorphan is a cough suppressant that affects a certain part of the brain (cough center), reducing the urge to cough. Acetaminophen is a non-aspirin pain reliever and fever reducer.
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 product package before taking this medication. If any of the information is unclear, consult your doctor or pharmacist.
Take this medication by mouth, usually every 4 to 6 hours as needed, or as directed by your doctor. This medication can be taken with food or milk if stomach upset occurs.
If you are using the liquid form, carefully measure the dose using a medication-measuring device or spoon. Do not use a household spoon because you may not get the correct dose. If your liquid is a suspension, shake the container well before measuring each dose.
If you are using chewable tablets, chew each tablet thoroughly before swallowing.
Dosage is based on age and weight. Check the package label to find the correct dose.
If you are treating yourself or a child for fever, consult your doctor immediately if the fever worsens or lasts more than 3 days. If the child has sore throat (especially with high fever, headache, rash, or nausea/vomiting), consult the doctor promptly.
If your condition persists for more than 7 days, if it worsens, if you develop new symptoms, or if you think you may have a serious medical problem, seek immediate medical attention.
See also Warning section.
Dizziness, drowsiness, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
If your doctor has directed you to use this medication, remember he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
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: rash, 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.
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 using this product, tell your doctor or pharmacist if you are allergic to dextromethorphan or acetaminophen; 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 product: breathing problems (e.g., asthma, emphysema), liver disease, use/abuse of alcohol.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Liquid products and chewable tablets may contain sugar or aspartame. Liquid products may also contain alcohol. 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 drug safely.
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. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
See also Warning section.
If your doctor has directed you to use this product, he or she may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, 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.
Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), isoniazid, ketoconazole.
The ingredients in this product are available in many prescription and nonprescription products. Check the labels on all your medications carefully to make sure you are not taking more than one product with the same ingredient(s). Consult your pharmacist if you are unsure of the ingredients in any of your medications.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., other cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
This medication may interfere with certain urine laboratory tests (e.g., 5-HIAA levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. 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, yellowing eyes/skin, dark urine, fast heartbeat, nervousness, abnormal/extreme feelings of well-being (euphoria), hallucinations, problems walking (staggering), agitation, severe drowsiness.
Keep all regular medical and laboratory appointments.
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 and resume your usual dosing schedule. Do not double the dose to catch up.
Refer to storage information printed on the package. Protect from light and moisture. Do not store in the bathroom. 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.
Information last revised June 2014. Copyright(c) 2014 First Databank, Inc.
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