Vicoprofen contains a combination of hydrocodone and ibuprofen. Hydrocodone is an opioid pain medication. An opioid is sometimes called a narcotic. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain, fever, and inflammation.

Vicoprofen is used short-term to relieve severe pain.

Vicoprofen is not for treating arthritis pain.

Taking Vicoprofen during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Hydrocodone can slow or stop your breathing, and may be habit-forming. MISUSE OF VICOPROFEN CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

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

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use Vicoprofen 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. These conditions can occur without warning while you are using ibuprofen, especially in older adults.

Before taking this medicine

You should not use Vicoprofen if you are allergic to hydrocodone or ibuprofen (Advil, Motrin), or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking Vicoprofen.

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Vicoprofen, especially in older adults.

To make sure Vicoprofen is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, fluid retention, diabetes, or if you smoke;

• stomach ulcers, or bleeding in your stomach or intestines;

• asthma or other breathing problems;

• liver or kidney disease;

• a head injury, brain tumor, or seizures;

• a problem with your gallbladder, pancreas, thyroid, or adrenal gland;

• urination problems;

• drug or alcohol addiction, or mental illness; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Some medicines can interact with hydrocodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use hydrocodone 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. Tell your doctor if you are pregnant.

Hydrocodone and ibuprofen can pass into breast milk and cause drowsiness or breathing problems in a nursing baby. Tell your doctor if you are breast-feeding.

Take Vicoprofen exactly as prescribed by your doctor. Follow all directions on your prescription label. Hydrocodone can slow or stop your breathing. Never take this medicine in larger amounts, or for longer than prescribed. Use the lowest dose that is effective in treating your condition. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydrocodone may be habit-forming. Never share Vicoprofen with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Vicoprofen is against the law.

If you need surgery, tell the surgeon ahead of time that you are using Vicoprofen. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Keep track of your medicine. Hydrocodone is a drug of abuse and you should be aware if anyone is using your Vicoprofen improperly or without a prescription.

Usual Adult Dose for Pain:

For short-term (generally less than 10 days) management of acute pain:
1 tablet every 4 to 6 hours as needed

Maximum dosage: 5 tablets in 24 hours

You should not use Vicoprofen if you are allergic to hydrocodone or ibuprofen (Advil, Motrin), or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Ibuprofen can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking Vicoprofen.

Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Vicoprofen, especially in older adults.

To make sure Vicoprofen is safe for you, tell your doctor if you have ever had:

• heart disease, high blood pressure, fluid retention, diabetes, or if you smoke;

• stomach ulcers, or bleeding in your stomach or intestines;

• asthma or other breathing problems;

• liver or kidney disease;

• a head injury, brain tumor, or seizures;

• a problem with your gallbladder, pancreas, thyroid, or adrenal gland;

• urination problems;

• drug or alcohol addiction, or mental illness; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Some medicines can interact with hydrocodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use hydrocodone 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. Tell your doctor if you are pregnant.

Hydrocodone and ibuprofen can pass into breast milk and cause drowsiness or breathing problems in a nursing baby. Tell your doctor if you are breast-feeding.

Since Vicoprofen is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A hydrocodone overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include vomiting, black or bloody stools, coughing up blood, confusion, muscle weakness, cold and clammy skin, slow heart rate, blue lips, noisy or shallow breathing, or fainting.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to ibuprofen. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Get emergency medical help if you have signs of an allergic reaction to Vicoprofen: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

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.

Stop using this medicine and call your doctor at once if you have:

• weak or shallow breathing, sighing, slow heartbeat;

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• the first sign of any 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 urinating, painful or difficult urination, swelling in your feet or ankles;

• low cortisol levels - vomiting, dizziness, worsening tiredness or weakness; or

• severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common Vicoprofen side effects may include:

• headache, dizziness, weakness;

• stomach pain, nausea, vomiting, indigestion, gas;

• constipation, diarrhea;

• feeling anxious or nervous;

• dry mouth;

• sweating, itching; or

• sleep problems (insomnia).

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.

Some medicines can cause unwanted or dangerous effects when used with Vicoprofen. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Taking Vicoprofen with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with hydrocodone and ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.