PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, codeine, or butalbital; or to other barbiturates (e.g., phenobarbital), salicylates (e.g., salsalate), nonsteroidal anti-inflammatory drugs (e.g., ibuprofen), narcotic pain medications (e.g., morphine) or xanthine derivatives (e.g., theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), breathing problems (e.g., chronic obstructive pulmonary disease-COPD, sleep apnea), bleeding/blood clotting disorders (e.g., hemophilia, von Willebrand's disease, thrombocytopenia), a certain enzyme disorder (porphyria), disease of the pancreas (e.g., pancreatitis), heart disease (e.g., irregular heartbeat, recent heart attack), certain enzyme deficiencies (pyruvate kinase or G6-PD deficiency), gout, liver disease, kidney disease, heartburn, growths in the nose (nasal polyps), a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, mental/mood disorders, stomach/intestinal problems (e.g., stomach/intestinal ulcers, infectious diarrhea, colitis), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), recent bowel/abdominal surgery.Before having surgery, tell your doctor or dentist that you are using this medication.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.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.This medication contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness.Some children may be more sensitive to very serious side effects of the codeine in this product, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, stomach/intestinal bleeding and ulcers, and trouble falling asleep. Confusion, dizziness, drowsiness and trouble falling asleep can increase the risk of falling.Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication is not recommended for use during pregnancy. It may harm an unborn baby and interfere with normal labor/delivery. Consult your doctor for more details.This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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