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.
If overdose is suspected, contact a poison control center or emergency room immediay. US residents can call their local poison control center at. 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, loss of consciousness.
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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.
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.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
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Some products that may interact with this drug include: certain pain medications (mixed narcotic agonist/antagonists such as pentazocine, nalbuphine, butorphanol), ketoconazole, narcotic antagonists (such as naltrexone).
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You are encouraged to report negative side effects of prescription drugs to the FDA.
This medication passes into breast milk and may rarely have undesirable effects on a nursing infant. l the doctor right away if your infant develops increased sleepiness, trouble breast-feeding, trouble breathing, or unusual limpness. Discuss the risks and benefits with your doctor before breast-feeding.
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Information last revised June 2014. 2014 First Databank, Inc.
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.
Children should not use products that contain codeine after certain surgeries (including tonsil/ adenoid removal). Also, for children younger than 12 years, do not use codeine to treat cough or pain unless specifically directed by the doctor. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). Talk with your doctor or pharmacist about the risks and benefits of this medication.
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.
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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 immediay.
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 affect breathing or cause drowsiness. Therefore, l your doctor or pharmacist if you are taking other products such as alcohol, allergy or cough-and-cold products, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as morphine), and psychiatric medicines (such as risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.
Codeine is changed into a strong narcotic drug (morphine) in your body. In some people, this change happens faster and more compley 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, unusual drowsiness/difficulty waking up, confusion.
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In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at.
If you have ongoing pain (such as due to cancer ), your doctor may direct you to also take long-acting narcotic medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other non-narcotic pain relievers (such as naproxen, ibuprofen ) may also be prescribed with this medication. Ask your doctor or pharmacist if you have any questions about using this product safely with other drugs.
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.).
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See also Warning section.
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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.
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.
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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking this product, l your doctor or pharmacist if you are allergic to acetaminophen or codeine; or to other narcotic 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.
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).
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
l your doctor if your pain persists or worsens.
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, l your doctor or pharmacist promptly.
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OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
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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.
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This combination medication is used to help relieve mild to moderate pain. It contains a narcotic pain reliever (codeine) and a non-narcotic pain reliever (acetaminophen). Codeine works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.
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.
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.
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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.
See also Warning section.
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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.
Before having surgery, l your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
l your doctor immediay if any of these unlikely but serious side effects occur: mental/mood changes, severe stomach/abdominal pain, difficulty urinating.
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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 ).
Other medications can affect how codeine works and your risk for side effects. Examples include cimetidine, quinidine, among others.
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.
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.
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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.
This medication may also be used to suppress a cough.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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.
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Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.
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.
Seek immediate medical attention if any of these rare but serious side effects occur: fainting, seizure.
GENERIC NAME(S): ACETAMINOPHEN WITH CODEINE PHOSPHATE.
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See also Warning section.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. l your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. l the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
Before using this medication, l 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 regular use/abuse of drugs/alcohol, 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 ).
See also Warning section.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior ( addiction ). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.
Daily alcohol use, especially when combined with acetaminophen, may damage your liver. Avoid alcohol.
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See also Warning section.
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