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Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine, or if you have porphyria.
Codeine and butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:
If you have any of these conditions, you may not be able to use acetaminophen, butalbital, caffeine, and codeine, or you may need a dosage adjustment or special tests during treatment.
Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.
FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Acetaminophen, butalbital, caffeine, and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Older adults may be more sensitive to the effects of this medicine.
Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
An overdose of acetaminophen can cause serious harm to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. One acetaminophen, butalbital, caffeine, and codeine capsule contains 325 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
Take this medicine with a full glass of water.
Take with food or milk to ease stomach upset.
Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
Acetaminophen, butalbital, caffeine, and codeine can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen, butalbital, caffeine, and codeine.
If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen, butalbital, caffeine, and codeine. You may need to stop using the medicine for a short time.
Store acetaminophen, butalbital, caffeine, and codeine at room temperature away from moisture and heat.
Keep track of how many tablets have been used from each new bottle of this medicine. Codeine is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
Report Problems to the Food and Drug Administration
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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