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See also Warning section.
This combination medication is used to help relieve mild to moderate pain. It contains an opioid (narcotic) pain reliever (codeine) and a non-opioid pain reliever (acetaminophen). Codeine works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.
See also Warning section.
Read the Medication Guide provided by your pharmacist before you start taking acetaminophen/codeine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).
If you are using a liquid form of this medication, use a medication measuring device to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose. If you are taking the suspension, shake the bottle well before each dose.
The dosage is based on your medical condition and response to treatment. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.
Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.
If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other pain relievers (such as naproxen, ibuprofen) may also be prescribed with this medication. Ask your doctor or pharmacist about using this product safely with other drugs.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions right away.
When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.
Tell your doctor if your pain persists or worsens.
See also Warning section.
Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because 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.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as agitation, depression, hallucinations), severe stomach/abdominal pain, difficulty urinating, fast/slow heartbeat, vision changes, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
Get medical help right away if you have any very serious side effects, including: fainting, seizure.
Codeine is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, severe drowsiness/difficulty waking up, confusion.
See also Warning section.
Before taking this product, tell your doctor or pharmacist if you are allergic to acetaminophen or codeine; or to other opioid pain medications (such as morphine); or if you have any other allergies. This product may contain inactive ingredients (such as metabisulfite), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), obesity, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis).
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 may contain sugar and alcohol. Caution is advised if you have diabetes, alcohol dependence, liver disease, 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 about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.) Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor.
This medication passes into breast milk and may rarely have undesirable effects on a nursing infant, such as unusual sleepiness, difficulty feeding, trouble breathing, or unusual limpness. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Store at room temperature away from light and moisture. Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets.
See also Warning section.
Some products that may interact with this drug include: certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol), naltrexone.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as morphine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Other medications can affect the removal of acetaminophen/codeine from your body, which may affect how acetaminophen/codeine works. Examples include azole antifungals (such as ketoconazole), bupropion, fluoxetine, macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), paroxetine, quinidine, rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory 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, give them naloxone if available, then call 911. If the person is awake and has no symptoms, 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: slow/shallow breathing, nausea, vomiting, loss of appetite, sweating, stomach/abdominal pain, slow heartbeat, extreme tiredness, yellowing eyes/skin, dark urine, coma.
If you are taking this medication on a regular schedule and you 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.
Do not share this medication with others. It is against the law.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.
Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.