SIDE EFFECTS: Nausea, vomiting, upset stomach, heartburn, constipation, lightheadedness, dizziness, drowsiness, increased sweating, or dry mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a 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: slow/shallow breathing, mental/mood changes (such as agitation, confusion, hallucinations), fainting, difficulty urinating, hearing changes (such as ringing in the ears, hearing loss), vision changes, fast/slow heartbeat, easy bruising/bleeding.
Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures, black/bloody stools, vomit that looks like coffee grounds, unusual tiredness, yellowing eyes/skin, dark urine, persistent nausea/vomiting.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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 product, tell your doctor or pharmacist if you are allergic to aspirin or codeine; or to salicylates (such as salsalate), nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen, naproxen, celecoxib), or to narcotic pain medications (such as 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), certain stomach/bowel diseases (paralytic ileus, infectious diarrhea), bleeding/blood clotting disorders (such as hemophilia, von Willebrand's disease, thrombocytopenia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), a certain spinal problem (kyphoscoliosis), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), personal or family history of regular use/abuse of drugs/alcohol, certain heart problems (irregular heartbeat, heart failure), brain disorders/injuries (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), gallbladder disease, disease of the pancreas (such as pancreatitis), adrenal gland problems (such as Addison's disease), mental/mood disorders (such as toxic psychosis), stomach/intestinal disorders (such as colitis, blockage, ulcer), heartburn, gout, growths in the nose (nasal polyps), certain enzyme deficiencies (pyruvate kinase deficiency, G6PD deficiency).
This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.
To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.
Before having surgery, tell your doctor or dentist that you are taking this medication.
This drug contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.
Older adults may be more sensitive to the effects of this drug, especially slow/shallow breathing, stomach bleeding, and drowsiness.
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. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.
This product passes into breast milk and may have undesirable effects on a nursing infant. Discuss the risks and benefits with your doctor before breast-feeding.