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. This product is not usually used for ongoing coughs from smoking, asthma, or other long-term breathing problems (e.g., 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).
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. In adults who do not have liver problems, the maximum dose of acetaminophen (one ingredient in this product) is 4 grams (4000 milligrams) per day. The maximum dose of acetaminophen for children is based on age/weight. Do not take more than the maximum daily amount because doing so may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: persistent nausea/vomiting, yellowing eyes/skin, dark urine, stomach/abdominal pain, unusual tiredness. If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication. 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.
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.
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