Carisoprodol, aspirin, and codeine

Take carisoprodol, aspirin, and codeine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If carisoprodol and codeine are taken regularly and in large amounts, it may become habit-forming (causing mental or physical dependence).

Dosing

The dose of carisoprodol, aspirin, and codeine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of carisoprodol, aspirin, and codeine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For relaxing muscles:
    • Adults and teenagers 16 years of age and older—1 or 2 tablets four times a day. One tablet contains 200 milligrams (mg) or carisoprodol, 325 mg of aspirin, and 16 mg of codeine.
    • Children younger than 16 years of age—Use and dose must be determined by your child's doctor.

Missed Dose

If you miss a dose of carisoprodol, aspirin, and codeine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Burning feeling in the chest or stomach
• indigestion
• stomach upset
• tenderness in the stomach area

• Cough
• difficult or troubled breathing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• shakiness and unsteady walk
• tightness in the chest
• unsteadiness, trembling, or other problems with muscle control or coordination

• Chills
• cold sweats
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• flushing or redness of the skin
• hearing loss
• hives
• itching
• painful or difficult urination
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusually warm skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Agitation or combativeness
• anxiety
• black, tarry stools
• bloody stools
• blue lips and fingernails
• change in consciousness
• cold, clammy skin
• confusion
• confusion as to time, place, or person
• coughing that sometimes produces a pink frothy sputum
• decreased awareness or responsiveness
• decreased urination
• depression
• diarrhea
• difficult, fast, or noisy breathing, sometimes with wheezing
• difficulty with sleeping
• disorientation
• drowsiness to profound coma
• dry mouth
• expressed fear of impending death
• extremely high fever or body temperature
• fainting
• fast or deep breathing
• fast, weak pulse
• hallucinations
• headache
• holding false beliefs that cannot be changed by fact
• irregular, fast or slow, or shallow breathing
• lethargy
• loss of consciousness
• loss of strength or energy
• mood or other mental changes
• muscle cramps
• muscle pain or weakness
• nausea
• pale or blue lips, fingernails, or skin
• pale, clammy skin
• pinpoint pupils
• severe sleepiness
• sunken eyes
• sweating
• swelling in the legs and ankles
• thirst
• unusual excitement, nervousness, or restlessness
• vomiting
• vomiting of blood or material that looks like coffee grounds
• wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Drowsiness

• Feeling of constant movement of self or surroundings
• sensation of spinning

• Hyperventilation
• irritability
• shaking
• trouble sleeping

• Constipation
• constricted, pinpoint, or small pupils (black part of the eye)
• relaxed and calm

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Very bad dizziness or passing out.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Feeling very sleepy.
• Ringing in ears.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Seizures.
• Very hard stools (constipation).
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.
• Not able to pass urine or change in how much urine is passed.
• Chest pain or pressure or a fast heartbeat.
• Change in balance.
• Shakiness.
• Low mood (depression).
• Feeling agitated.
• Feeling confused.
• Fever or chills.
• A very bad and sometimes deadly health problem called serotonin syndrome may happen if you take carisoprodol, aspirin, and codeine with drugs for depression, migraines, or certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
• Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet: Carisoprodol 200 mg, aspirin 325 mg, and codeine phosphate 16 mg

See individual agents.

Musculoskeletal conditions: Oral: 1 to 2 tablets 4 times a day for a maximum recommended duration of 2 to 3 weeks (maximum: 8 tablets/24 hours)

Discontinuation in patients on long-term therapy: Although this combination product should only be used for short periods (2 to 3 weeks), in patients with a history of long term use or high doses, carisoprodol should be tapered off slowly (eg, over 14 days) to avoid withdrawal symptoms such as anxiety, insomnia, or irritability (Eleid 2010).

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).