This medicine is a narcotic and analgesic combination used to relieve moderate to moderately severe pain. It may also be used to treat other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. TAKE THIS MEDICINE by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. IF YOU HAVE BEEN TAKING THIS MEDICINE REGULARLY or for longer than a few weeks, do not suddenly stop taking it without checking with your doctor. Your doctor may need to gradually lower your dose. SOME OF THESE PRODUCTS CONTAIN SULFITES. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
WARNING: THIS MEDICINE CONTAINS ACETAMINOPHEN. Severe and sometimes fatal liver problems, including the need for liver transplant, have been reported with the use of acetaminophen. Most cases of these liver problems occurred in patients taking excessive doses of acetaminophen (more than 4,000 mg per day). Also, patients who developed these liver problems were often using more than 1 medicine that contained acetaminophen. Discuss any questions or concerns with your doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking sodium oxybate (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), buprenorphine, isoniazid, linezolid, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), naltrexone, other narcotic pain medicines (eg, morphine), perampanel, sleep medicines (eg, zolpidem), tricyclic antidepressants (eg, amitriptyline), or medicines that may harm the liver (eg, methotrexate, ketoconazole, certain medicines for HIV infection). Ask your doctor if you are unsure if any of your medicines might harm the liver. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of liver problems (eg, hepatitis), kidney problems, lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease / COPD), drug or alcohol abuse or dependence, heart problems (eg, cor pulmonale, slow or irregular heartbeat), low blood pressure, stomach or bowel problems (eg, blockage, inflammation, paralysis), gallbladder problems, prostate problems (eg, an enlarged prostate), difficulty urinating, seizures, thyroid problems, adrenal gland problems (eg, Addison disease), mental or mood problems, inflammation of the pancreas (pancreatitis), curvature of the spine (scoliosis), suicidal thoughts or actions, allergies, pregnancy, or breast-feeding. Tell your doctor if you have severe drowsiness, or have or recently have had any head injury, increased pressure in the brain, growths in the brain (eg, tumors), or infection of the brain or nervous system. Tell your doctor if you have recently had surgery (eg, stomach or bowel surgery) or are scheduled to have surgery. Tell your doctor if you are in very poor health; are very overweight or are dehydrated; have low blood volume, stomach pain, or constipation; drink alcohol; or are going through withdrawal from alcohol or other substances. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have very slow or difficult breathing, or you are having an asthma attack. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include dizziness, drowsiness, lightheadedness, nausea, or vomiting. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY CAUSE CONSTIPATION. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking this medicine, talk with your doctor or pharmacist. CONTACT YOUR DOCTOR IMMEDIATELY if you experience a change in the amount of urine produced; change or loss in hearing; chest pain; confusion; fainting; fever, chills, or persistent sore throat; mental or mood changes (eg, agitation, anxiety, depression); red, swollen, blistered, or peeling skin; severe or persistent constipation; severe or persistent dizziness, drowsiness, headache, or lightheadedness; shortness of breath; slow, shallow, or difficult breathing; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, persistent loss of appetite, unusual or severe stomach pain); trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; or vision changes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; or unusual hoarseness. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms of overdose may include bluish skin or nails; cold and clammy skin; coma; decreased urination; difficult, shallow, or slow breathing; fainting; limp muscles; loss of consciousness; nausea or vomiting; pinpoint pupils; seizures; severe dizziness, drowsiness, or light-headedness; slow heartbeat; symptoms of liver problems (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite, unusual or severe stomach pain); unusual bruising or bleeding; or unusual sweating or tiredness.
If your symptoms do not improve or if they become worse, contact your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.