Xylon 10 (Generic)

This combination medication is used for a short time (usually less than 10 days) to help relieve moderate to severe pain. It contains an opioid pain reliever (hydrocodone) and a nonsteroidal anti-inflammatory drug-NSAID (ibuprofen). Hydrocodone works in the brain to change how your body feels and responds to pain. Ibuprofen reduces pain and fever.

This product is not recommended for use in children younger than 6 years due to an increased risk of serious side effects (such as slow/shallow breathing).

This medication is not intended to treat long-term conditions (such as arthritis).

Read the Medication Guide provided by your pharmacist before you start using this medication 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, usually every 4 to 6 hours as needed. Take it with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug. 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).

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. 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. The manufacturer recommends you take no more than 5 tablets in a 24-hour period.

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. Also follow your doctor's or pharmacist's directions for the safe use of other non-opioid pain relievers (such as acetaminophen).

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

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 does not get better or if it gets worse.

See also Warning section.

Upset stomach, nausea, vomiting, constipation, dizziness, lightheadedness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

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: easy bruising/bleeding, fast/pounding heartbeat, difficult/painful swallowing, interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), difficulty urinating, unusual weakness, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss), symptoms of heart failure (such as swelling ankles/feet, unusual/sudden weight gain).

Stop taking this medication and get medical help right away if any of these very serious side effects occur: fainting, slow/irregular/shallow breathing, signs of kidney problems (such as change in the amount of urine), severe drowsiness/difficulty waking up, unexplained fever, persistent/severe headache, unexplained stiff neck, seizure.

This drug may rarely cause serious, possibly fatal, liver disease. Stop taking this medication and get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash/blisters, 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.

Before taking this medication, tell your doctor or pharmacist if you are allergic to ibuprofen or hydrocodone; or to aspirin or other NSAIDs (such as naproxen, celecoxib); or to other opioids (such as benzhydrocodone, codeine, morphine, hydromorphone); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), low red blood cell count (anemia), bleeding or clotting problem, brain disorders (such as head injury, tumor, seizures, stroke), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), growths in the nose (nasal polyps), high blood pressure, heart problems (such as irregular heartbeat, recent heart attack), liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), stomach/intestinal problems (such as ulcer, blockage, constipation, diarrhea due to infection, paralytic ileus), fluid retention/swelling of the ankles/feet/hands, difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis).

Kidney problems can sometimes occur with the use of NSAID medications, including ibuprofen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.

Older adults may be at greater risk for dizziness, drowsiness, confusion, stomach/intestinal bleeding, kidney problems, heart attack, stroke, and slow/shallow breathing while using this drug.

Children may be more sensitive to the side effects of this drug, especially 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. (See also Warning section.) This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Different brands of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. 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. For more details, read the Medication Guide, or consult your pharmacist or local waste disposal company.

See also Warning section.

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.

Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), corticosteroids (such as prednisone), lithium, naltrexone, pemetrexed, probenecid, certain pain medications (mixed opioid agonist-antagonists such as pentazocine, nalbuphine, butorphanol).

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Other medications can affect the removal of hydrocodone/ibuprofen from your body, which may affect how hydrocodone/ibuprofen works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), mifepristone, HIV medications (such as ritonavir), rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

Check all prescription and nonprescription medicine labels carefully for ibuprofen or other pain/fever drugs (aspirin, NSAIDs such as celecoxib, ketorolac, or naproxen). These drugs are similar to ibuprofen, so taking one of these drugs while also taking ibuprofen may increase your risk of side effects. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise.

Daily use of ibuprofen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain. If you must take ibuprofen, talk to your doctor about taking immediate-release aspirin (not enteric-coated/EC) while taking ibuprofen. Take this product at least 8 hours before or at least 2 hours after your aspirin dose. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.

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 codeine, oxycodone), alcohol, marijuana (cannabis), 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.

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 breathing, fast/slow/irregular heartbeat, coma.

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. Take your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others. Sharing it is against the law.

Laboratory and/or medical tests (such as kidney function tests) may be performed to check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. 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.