When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to carisoprodol, codeine, aspirin, or meprobamate, you are pregnant or breastfeeding, or you have a history of bleeding problems, porphyria, or stomach or bowel problems (such as blockage, perforation) caused by aspirin.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Drink plenty of liquids to help avoid constipation.
• This medicine is not for long-term use. Do not use this medicine for more than 2 to 3 weeks (14 to 21 days) to treat pain unless your doctor has told you to.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how this medicine works. Tell your doctor if you are taking any of the following:
  
  • Acetazolamide
  • Blood pressure medicine, such as atenolol, benazepril, enalapril, hydrochlorothiazide (HCTZ), lisinopril, metoprolol, propranolol
  • Blood thinner medicine, such as clopidogrel, heparin, warfarin
  • Fluvoxamine
  • Insulin, or oral diabetes medicine, such as glimepiride, glipizide, glyburide, metformin
  • Methotrexate
  • NSAID pain or arthritis medicine, such as aspirin, diclofenac, ibuprofen, naproxen, celecoxib
  • Omeprazole
  • Phenothiazine medicine, such as promethazine, chlorpromazine
  • Probenecid or sulfinpyrazone
  • Rifampin
  • Steroid medicine, such as dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone
  • St John's wort
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you usually have 3 or more drinks of alcohol per day.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have kidney disease, liver disease, digestive system problems (such as stomach ulcers), lung disease or breathing problems (such as COPD or sleep apnea), asthma with nasal polyps and rhinitis, or a history of head injury or addiction to drugs or alcohol.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• This medicine may cause bleeding in your stomach or intestines, without warning signs. Bleeding is more likely if you had a stomach ulcer, drink alcohol regularly, are older than 60 years, or are using certain other medicines (such as a blood thinner or NSAID).
• This medicine is not meant for use in children. Serious breathing problems and deaths have occurred when children have been given codeine.
• Do not give aspirin to a child or teenager who has chickenpox or flu symptoms, unless approved by a doctor. Aspirin can cause a life-threatening reaction called Reye syndrome.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Call your doctor if your symptoms do not improve or if they get worse.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or black, tarry stools
• Lightheadedness, dizziness, or fainting
• Ringing in your ears
• Severe constipation, stomach pain, nausea
• Seizure, extreme sleepiness, trouble breathing, uneven, fast, slow, or shallow breathing, vomiting, confusion, pinpoint pupils
• Vomiting blood or material that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Restlessness or irritability
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088