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Medication Guide
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Carisoprodol (kar-eye-soe-PROE-dol), Aspirin (ASS-per-in), and Codeine Phosphate (koe-DEEN fos-feyt) Tablets, CIII
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Carisoprodol, Aspirin, and Codeine Phosphate Tablets are:
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- A strong prescription pain medicine that contains an opioid (narcotic) that is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
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- An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
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- Carisoprodol, Aspirin and Codeine Phosphate Tablets should only be used for up to 2 or 3 weeks. It is not known if Carisoprodol, Aspirin and Codeine Phosphate Tablets is effective when used for longer periods.
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Important information about Carisoprodol, Aspirin, and Codeine Phosphate Tablets:
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Get emergency help right away if you take too much Carisoprodol, Aspirin, and Codeine Phosphate Tablets (overdose). When you first start taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
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- Taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
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- Never give anyone else your Carisoprodol, Aspirin, and Codeine Phosphate Tablets. They could die from taking it. Selling or giving away Carisoprodol, Aspirin, and Codeine Phosphate Tablets is against the law.
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- Store Carisoprodol, Aspirin, and Codeine Phosphate Tablets securely, out of sight and reach of children and in a location not accessible by others, including visitors to the home.
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Important Information Guiding Use in Pediatric Patients:
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- Do not give Carisoprodol, Aspirin, and Codeine Phosphate Tablets to a child younger than 12 years of age.
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- Do not give Carisoprodol, Aspirin, and Codeine Phosphate Tablets to a child younger than 18 years of age to treat pain after surgery to remove the tonsils and/or adenoids.
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- Avoid giving Carisoprodol, Aspirin, and Codeine Phosphate Tablets to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.
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- Do not give Carisoprodol, Aspirin, and Codeine Phosphate Tablets to a child or teenager with a viral illness. Reye syndrome, a life-threatening condition, can happen when aspirin (an ingredient in Carisoprodol, Aspirin, and Codeine Phosphate Tablets) is used in children and teenagers who have certain viral illnesses.
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Do not take Carisoprodol, Aspirin, and Codeine Phosphate Tablets if you have:
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- severe asthma, trouble breathing, or other lung problems.
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- a bowel blockage or have narrowing of the stomach or intestines.
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- known allergy to nonsteroidal anti-inflammatory drug products (NSAIDs)
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- a rare disorder in which your blood doesn’t clot normally (hemophilia)
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Before taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets, tell your healthcare provider if you have a history of:
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- head injury, seizures
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- liver, kidney, thyroid problems
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- problems urinating
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- pancreas or gallbladder problems
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- abuse of street or prescription drugs, alcohol addiction, or mental health problems
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- have been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines
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Tell your healthcare provider if you are:
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pregnant or planning to become pregnant. Carisoprodol, Aspirin, and Codeine Phosphate Tablets may harm your unborn baby. Prolonged use of Carisoprodol, Aspirin, and Codeine Phosphate Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
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breastfeeding. Not recommended; may harm your baby.
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- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets with certain other medicines can cause serious side effects that could lead to death.
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When taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets:
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- Do not change your dose. Take Carisoprodol, Aspirin, and Codeine Phosphate Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
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- Take your prescribed dose of 1 or 2 tablets 4 times daily. Total daily dosage should not exceed 8 tablets. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
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- Call your healthcare provider if the dose you are taking does not control your pain.
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- If you have been taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets regularly, do not stop taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets without talking to your healthcare provider.
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- Dispose of expired, unwanted, or unused Carisoprodol, Aspirin, and Codeine Phosphate Tablets by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of Carisoprodol, Aspirin, and Codeine Phosphate Tablets by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash.
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While taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets DO NOT:
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- Drive or operate heavy machinery, until you know how Carisoprodol, Aspirin, and Codeine Phosphate Tablets affects you. Carisoprodol, Aspirin, and Codeine Phosphate Tablets can make you sleepy, dizzy, or lightheaded.
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- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Carisoprodol, Aspirin, and Codeine Phosphate Tablets may cause you to overdose and die.
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The possible side effects of Carisoprodol, Aspirin, and Codeine Phosphate Tablets:
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- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
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Get emergency medical help if you have:
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- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
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- If you are a nursing mother taking Carisoprodol, Aspirin, and Codeine Phosphate Tablets and your breastfeeding baby has increased sleepiness, confusion, difficulty breathing, shallow breathing, limpness, or difficulty breastfeeding.
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- These are not all the possible side effects of Carisoprodol, Aspirin, and Codeine Phosphate Tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
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Distributed by: Sandoz Inc. Princeton, NJ 08540
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