HYDROCODONE(10) + IBUPROFEN(200) BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP LIVER PROBLEMS; KIDNEY DISEASE; ASTHMA; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Take this medicine WITH food, a meal, or a snack. Do not take on an empty stomach. * DO NOT EXCEED recommended dosage; excessive use may lead to adverse effects or loss of effectiveness. Do not adjust the dose unless instructed. * Do not DISCONTINUE this medicine ABRUPTLY after prolonged usage. WARNINGS/PRECAUTIONS: TOP * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):- * shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. * DO NOT TAKE if you ever had any unusual or allergic reaction to aspirin, ibuprofen, naproxen, or any medicine used to treat pain, fever, or arthritis. * There are no adequate or well-controlled safety studies in pregnant women. NOTIFY YOUR DOCTOR IF PREGNANT or intend to become pregnant. * AVOID concurrent use of alcohol or other CNS depressants as it may intensify the drowsiness, dizziness, or lightheadedness effect of this medicine. * This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT drive or operate machines until you know how you react to this medicine. * This medicine may cause dizziness, lightheadedness or fainting. Avoid sudden changes in posture. BE CAREFUL and slowly sit up or stand up. * Prolonged use of this medication may cause physical and psychological dependence, do not exceed recommended dose. * Inform doctor or dentist that you are taking this medicine BEFORE HAVING ANY KIND OF SURGERY including dental surgery or medical procedure. ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience: Shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Skin rash; Swelling of feet or lower legs; Visual disturbances; Itching; Stomach or intestinal bleeding; Weight gain; Headache; Shortness of breath; Irregular heartbeat; Low blood pressure; Hot sensation and redness of face. Other Common Side Effects: TOP Gastric or intestinal ulcers; Constipation; Nausea; Sedation; Dizziness; Heartburn; Vomiting; Dry mouth; Sweating; Rapid heart rate; High blood pressure; Abnormal blood cell count; Confusion; Drowsiness; Congestive heart failure; Hallucinations; Liver inflammation; Difficulty falling asleep; Severe skin reactions; Fluid retention; Stomach or intestinal perforation; Nervousness; Ringing in ears; Respiratory depression; Stomach discomfort or pain; Indigestion; Unusual tiredness or weakness; Severe skin itching with patches; Slowness of heartbeat; Cns depression. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved