Hydrocodone is an opioid pain medicine. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). This combination medicine is used short-term to relieve severe pain.

Hydrocodone and ibuprofen may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to hydrocodone or ibuprofen, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizure;
• liver or kidney disease;
• high blood pressure, heart problems, or a heart attack;
• problems with your gallbladder, pancreas, or thyroid;
• urination problems; or
• drug or alcohol addiction, or mental illness.

If you are pregnant, you should not take this medicine unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious problems in the unborn baby and possible complications with your pregnancy. If you take opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using this medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Use Xylon 10 (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

• weak or shallow breathing, sighing, slow heartbeat, breathing that stops during sleep;
• swelling, rapid weight gain;
• a skin rash, no matter how mild;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--loss of appetite, diarrhea, upper stomach pain, tiredness, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• low cortisol levels--vomiting, dizziness, worsening tiredness or weakness; or
• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

• dizziness, drowsiness;
• stomach pain, nausea, vomiting, heartburn, gas;
• constipation, diarrhea; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to ibuprofen (such as aspirin, ketoprofen, or naproxen).