Acetaminophen, butalbital, caffeine, and codeine

Codeine is an opioid pain medication (sometimes called a narcotic). Acetaminophen is a less potent pain reliever. Butalbital is a barbiturate that relaxes muscle contractions. Caffeine is a stimulant that relaxes blood vessels to improve blood flow.

Acetaminophen, butalbital, caffeine, and codeine is a combination medicine used to treat tension headaches.

Acetaminophen, butalbital, caffeine, and codeine may also be used for purposes not listed in this medication guide.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death.

Follow all directions on your prescription label. Codeine can slow or stop your breathing. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Butalbital and codeine may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away this medicine is against the law.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using the medicine.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Butalbital and codeine are drugs of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include extreme drowsiness, pinpoint pupils, cold and clammy skin, weak pulse, shallow breathing, fainting, or breathing that stops.

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

• drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen, butalbital, caffeine, and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Use with caution

US BOXED WARNING: HEPATOTOXICITY AND DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE
-Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most cases of liver injury are associated with acetaminophen use at doses that exceed 4000 mg per day, and often involve more than 1 acetaminophen-containing product.
-Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to CYP2D6 polymorphism.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule III

Data not available

Administration advice:
-Take orally as needed
-Do not exceed 6 capsules/tablets per day or 180 mL of oral liquid per day; do not exceed 4000 mg of acetaminophen per day; when calculating daily acetaminophen doses, be sure to include all acetaminophen-containing products and all routes of administration.
-Oral liquid is 7.368% alcohol.

Storage requirements: Protect from light and moisture

General:
-Butalbital and codeine are drugs that may be abused; extended use is not recommended.
-Acetaminophen induced hepatotoxicity is mostly preventable by ensuring maximum daily doses are not exceeded; use of more than 1 acetaminophen-containing product at one time should be discouraged as the use of multiple acetaminophen-containing products increases the risk of excess acetaminophen doses.
-Serious skin reaction may occur; discontinue therapy at first appearance of skin rash or any other sign of hypersensitivity.

Monitoring:
-Monitor for potential abuse
-Monitor for respiratory depression and signs of morphine overdose
-Monitor for nausea, vomiting, loss of appetite, sweating, extreme tiredness, unusual bleeding or bruising, pain in upper right part of the stomach, yellow of the skin or eyes, and/or flu-like symptoms as this may be an indication of acetaminophen overdose.
-Monitor for skin reactions

Patient advice:
-Patients should be advised that this drug has the potential to cause physical and psychological dependence, and tolerance; patients should be instructed to take this drug as prescribed, in the amounts prescribed, and no more frequently than prescribed.
-Patients should understand the risks of life-threatening respiratory depression and when this risk is greatest, patients should be aware that a genetic mutation may result in greater toxicity in some patients.
-Patients should be advised that severe liver damage may occur if more than the recommended amount of acetaminophen is taken; if they suspect they may have taken too much acetaminophen or if they experience nausea, vomiting, loss of appetite, or yellowing of the skin or eyes they should seek medical help promptly.
-Patients should be discouraged from using multiple acetaminophen-containing products concurrently; patients should be instructed to check with their healthcare provider or pharmacist if they have questions on what products contain acetaminophen.
-Patients should be advised to avoid alcohol use while taking this drug.
-Patients should be advised to avoid potentially hazard tasks such as driving a car while taking this drug.
-Women of childbearing potential should be advised to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.