acetaminophen, butalbital, caffeine, and codeine

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Pronunciation: a SEET a MIN o fen, bue TAL bi tal, KAF een, and KOE deen

Brand: Fioricet with Codeine

APAP-Butalbital-Caffeine-Codeine Cap-WAT

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capsule, blue/white, imprinted with WATSON, 3220

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Fioricet with Codeine

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capsule, blue/gray, imprinted with FIORICET CODEINE, LOGO

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What is the most important information I should know about this medicine?

You should not use this medicine if you have porphyria.

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

Get emergency medical help if a child taking this medication has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

What is this acetaminophen, butalbital, caffeine, and codeine?

Codeine is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in 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.

What should I discuss with my healthcare provider before taking this medicine?

You should not use this medicine if you are allergic to acetaminophen, butalbital, caffeine, or codeine, or if you have porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

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, especially in a child.

Medicines that contain codeine should not be given to a child just after surgery to remove the tonsils or adenoids.

To make sure this medicine is safe for you, tell your doctor if you have:

  • liver disease, alcoholism, or if you drink more than 3 alcoholic beverages per day;
  • asthma, COPD, sleep apnea, or other breathing disorders;
  • kidney disease;
  • a history of head injury or brain tumor;
  • an enlarged prostate or urination problems;
  • a thyroid or adrenal gland disorder;
  • mental illness; or
  • a history of drug or alcohol addiction.

Some medicines can interact with codeine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use butalbital or codeine while you are pregnant, your baby could become dependent on these drugs. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

This medication 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 breast-feed while taking this medicine.

How should I take this medicine?

Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose of acetaminophen 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. Keep the medication in a place where others cannot get to it. 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.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using this medication.

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.

What happens if I miss a dose?

Since this medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness or insomnia, restless feeling, tremors, fast heart rate, pinpoint pupils, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking this medicine?

Drinking alcohol can increase dangerous side effects of butalbital or codeine.

This medication may cause blurred vision and may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medication will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

What are the possible side effects of this medicine?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Seek emergency medical attention if a child taking this medication has any of the following life-threatening side effects: noisy breathing, sighing, slow breathing with long pauses between breaths; being unusually sleepy or hard to wake up; blue colored lips.

Stop using this medicine and call your doctor at once if you have:

  • weak or shallow breathing, slow heart rate, feeling like you might pass out;
  • fast or pounding heart rate, feeling short of breath;
  • confusion, hallucinations, unusual thoughts or behavior;
  • muscle twitching, feelings of extreme happiness or sadness;
  • easy bruising or bleeding;
  • little or no urination;
  • infertility, missed menstrual periods, impotence, sexual problems, loss of interest in sex;
  • liver problems --nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • low cortisol levels -- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

Common side effects include:

  • drowsiness, dizziness, feeling "drunk";
  • mild nausea, vomiting, stomach pain; or
  • feeling restless or anxious.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen, butalbital, caffeine, and codeine?

Some medicines can cause unwanted or dangerous effects when used together. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, muscle relaxer, other narcotic pain medicine, or medicine for anxiety, depression, or seizures.

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.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen, butalbital, caffeine, and codeine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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