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.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking hydrocodone and ibuprofen during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Follow the directions on your prescription label and read all medication guides. Never use hydrocodone and ibuprofen in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Store at room temperature away from moisture and heat.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Usual Adult Dose for Pain:

1 tablet orally every 4 to 6 hours as needed
Maximum dose: 5 tablets in 24 hours
Duration of therapy: Generally less than 10 days

Comments:
-The lowest effective dose or the longest dosing interval should be sought for each patient.
-Each tablet provides a combination of ibuprofen 200 mg and either hydrocodone 2.5, 5, 7.5, or 10 mg.
-Because of the risks of addiction and abuse, this drug should be reserved for use in patients for whom alternative treatment options have not been tolerated, or are not expected to be tolerated; or have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Use: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Pediatric Dose for Pain:

16 years or older:

1 tablet orally every 4 to 6 hours as needed
Maximum dose: 5 tablets in 24 hours
Duration of therapy: Generally less than 10 days

Comments:
-The lowest effective dose or the longest dosing interval should be sought for each patient.
-Each tablet provides a combination of ibuprofen 200 mg and either hydrocodone 2.5, 5, 7.5, or 10 mg.
-Because of the risks of addiction and abuse, this drug should be reserved for use in patients for whom alternative treatment options have not been tolerated, or are not expected to be tolerated; or have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Use: For the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

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.

Since hydrocodone and ibuprofen is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include black or bloody stools, coughing up blood, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Avoid driving or hazardous activity until you know how hydrocodone and ibuprofen 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).

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.

Hydrocodone and ibuprofen may cause serious side effects. 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 of hydrocodone and ibuprofen 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.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other opioids--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Ativan, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect hydrocodone and ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.