SIDE EFFECTS: See also Warning section.
Upset stomach, nausea, vomiting, constipation, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).
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 immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, fainting, difficult/painful swallowing, hearing changes (e.g., ringing in the ears), mental/mood changes, persistent/severe headache, slow/shallow breathing, stomach pain, swelling of hands/feet, sudden/unexplained weight gain, vision changes.
Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), change in the amount of urine, seizures, unexplained stiff neck.
This drug may rarely cause serious, possibly fatal liver disease. If you notice any of the following rare but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching, swelling (especially of throat/face), 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.
Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to ibuprofen or hydrocodone; or to aspirin or other NSAIDs (e.g., naproxen, celecoxib); or to narcotic pain medications (e.g., codeine, morphine); or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), severe breathing problems (e.g., respiratory depression, hypercapnia), a certain bowel disease (paralytic ileus), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problem (e.g., Addison's disease), asthma, blood disorders (e.g., anemia), bleeding or clotting problem, brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), poorly controlled diabetes, gallbladder disease, growths in the nose (nasal polyps), heart problems (e.g., congestive heart failure, irregular heartbeat, recent heart attack), high blood pressure, kidney disease, liver disease, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, hypoxia, hypercapnia), mental/mood disorders (e.g., toxic psychosis), disease of the pancreas (e.g., pancreatitis), a certain spinal problem (kyphoscoliosis), stomach/intestine/esophagus problems (e.g., bleeding, ulcers, recurring heartburn), stroke, swelling of the ankles/feet/hands, a severe loss of body water (dehydration), personal or family history of regular use/abuse of drugs/alcohol, underactive thyroid (hypothyroidism), difficulty urinating (e.g., due to enlarged prostate or urethral narrowing).
Before having surgery, tell your doctor or dentist that you are using this medication.
This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or taking part in any other activity that requires alertness. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Limit alcoholic beverages because they may increase the risk of this drug's side effects.
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. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
Caution is advised when this product is used in the elderly because they may be more sensitive to its side effects, especially slow/shallow breathing, stomach bleeding, and kidney effects.
During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Use of this medication near or at the time of delivery may have undesirable side effects (e.g., slow/shallow breathing) on the newborn. Discuss the risks and benefits with your doctor.
It is not known if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.