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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

slide 1 of 2, APAP-Butalbital-Caffeine-Codeine Cap-WAT,

capsule, blue/white, imprinted with WATSON, 3220

Image of APAP-Butalbital-Caffeine-Codeine Cap-WAT
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Fioricet with Codeine

slide 2 of 2, Fioricet with Codeine,

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

Image of Fioricet with Codeine
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What is the most important information I should know about this medicine?

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

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 a barbiturate. 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:

  • severe breathing problems;
  • a stomach or bowel obstruction;
  • porphyria; or
  • if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

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

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.

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.

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

  • liver or kidney disease;
  • asthma or other breathing disorders;
  • a history of head injury, brain tumor, or seizures;
  • urination problems;
  • problems with your gallbladder, thyroid, or adrenal gland;
  • mental illness, or a history of drug or alcohol addiction; or
  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

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.

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. 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.

What happens if I miss a dose?

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use 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.

Overdose symptoms may include nausea, vomiting, sweating, extreme drowsiness, muscle weakness, slow heart rate, pinpoint pupils, cold and clammy skin, fainting, weak pulse, coma, shallow breathing, or no breathing.

What should I avoid while taking this medicine?

Do not drink alcohol. Dangerous side effects or death could occur.

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.

Like other narcotic medicines, codeine can slow your breathing. Death may occur if breathing becomes too weak.

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.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal, 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.

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;
  • chest pain, fast or pounding heart rate, feeling short of breath;
  • confusion, hallucinations, unusual thoughts or behavior;
  • muscle twitching, feelings of extreme happiness or sadness;
  • little or no urination;
  • a seizure (convulsions);
  • 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";
  • nausea, vomiting, stomach pain, constipation; or
  • headache, feeling tired.

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?

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.

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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