DEXTROMETHORPHAN/ACETAMINOPHEN/ANTIHISTAMINE - ORAL

DEXTROMETHORPHAN/ACETAMINOPHEN/ANTIHISTAMINE - ORAL

PHONETIC PRONUNCIATION:

GENERIC NAME(S): dextromethorphan HBr/acetaminophen/doxylamine

Uses

USES: 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).


How to use DEXTROMETHORPHAN/ACETAMINOPHEN/ANTIHISTAMINE - ORAL

HOW TO USE: 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.

Side Effects

SIDE EFFECTS: 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, seizure. 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 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.

Precautions

PRECAUTIONS: 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), diabetes, glaucoma, heart problems, high blood pressure, kidney problems, liver disease, seizures, 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 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. 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.

Interactions

DRUG INTERACTIONS: See also Warning section. If you are taking this product under your doctor's direction, your doctor or pharmacist 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 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. Before using this product, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray), ketoconazole. 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, 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 laboratory tests (including urine 5-HIAA), 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.

Overdose

OVERDOSE: 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.

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Faq for DEXTROMETHORPHAN/ACETAMINOPHEN/ANTIHISTAMINE - ORAL

- This medication is used to relieve symptoms of cold, flu, allergies, or other breathing illnesses such as bronchitis or sinusitis. It helps alleviate coughs, runny nose, sneezing, itching, and watery eyes.

- Dextromethorphan is a cough suppressant that works by decreasing activity in the part of the brain that triggers the cough reflex.

- Acetaminophen is a pain reliever and fever reducer that helps alleviate symptoms such as headache, sore throat, and fever.

- The antihistamine in this medication helps to relieve symptoms such as sneezing, itching, and watery eyes caused by allergies or the common cold.

- No, this medication is typically available only with a prescription from a healthcare professional.

- Common side effects may include drowsiness, dizziness, upset stomach, blurred vision, dry mouth, or constipation. However, not everyone experiences these side effects.

- It is important to consult a doctor or pharmacist before taking this medication if you have high blood pressure or any other medical condition. Some components may interact with existing medications or exacerbate certain conditions.

- The dosage and frequency of this medication will depend on your age, medical condition, and response to treatment. Always follow the directions provided by your healthcare professional or the instructions on the medication label.

- It is essential to consult a healthcare professional before taking any medication during pregnancy or while breastfeeding. They will evaluate the potential risks and benefits to determine if this medication is suitable.


Warning

WARNING: 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


Disclaimer

IMPORTANT: 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.