codeine/carisoprodol/aspirin - oral, Soma Compound with Codeine (cont.)
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to codeine, carisoprodol, or aspirin; or to related medications such as meprobamate, tybamate, or mebutamate; or to other narcotic pain medications (such as morphine); or to nonsteroidal anti-inflammatory drugs-NSAIDs (such as ibuprofen); 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), growths in the nose (nasal polyps), stomach/intestine/esophagus problems (such as ulcers, heartburn, blockage, constipation, diarrhea due to infection, paralytic ileus), a certain blood disorder (acute intermittent porphyria), brain disorders (such as head injury, tumor, seizures), breathing problems (such as sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, bleeding/clotting disorders (such as hemophilia, von Willebrand disease, thrombocytopenia), certain enzyme deficiencies (such as G6PD or pyruvate kinase deficiency), gout, personal or family history of regular use/abuse of drugs/alcohol, mental/mood disorders (such as confusion, depression, thoughts of suicide), difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).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. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.This drug 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 recently received a vaccine. In these cases, taking aspirin increases the risk of 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 stomach/intestinal bleeding and ulcers, dizziness, drowsiness, weakness, confusion, slow/shallow breathing, and difficulty urinating. Dizziness, drowsiness, and confusion 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. Do not use this medication during the last 3 months of pregnancy because of possible harm to the unborn baby or problems during delivery. Consult your doctor for more details.This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. 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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