Acetaminophen, butalbital, caffeine, and codeine
Generic Name: acetaminophen, butalbital, caffeine, and codeine (a SEET a MIN o fen, bue TAL bi tal, KAF een, and KOE deen)
Brand Name: Fioricet with Codeine, Phrenilin with Caffeine and Codeine
What is this 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.
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Do not give this medicine to anyone younger than 12 years old, or anyone under 18 who recently had surgery to remove the tonsils or adenoids.
Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
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 asthma or breathing problems;
a blockage in your stomach or intestines;
This medicine is not approved for use by anyone younger than 12 years old.
Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.
Tell your doctor if you have ever had:
liver or kidney disease;
problems with your gallbladder, thyroid, or adrenal gland; or
If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.
Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.
How should I take acetaminophen, butalbital, caffeine, and codeine?
Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.
Never share opioid medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid 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 your medicine. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Since acetaminophen, butalbital, caffeine, and codeine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.
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, especially in a child or another person using the medicine without a prescription. Overdose can cause severe muscle weakness, pinpoint pupils, very slow breathing, extreme drowsiness, or coma.
What should I avoid while taking acetaminophen, butalbital, caffeine, and codeine?
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking too much acetaminophen can lead to a fatal overdose.
acetaminophen, butalbital, caffeine, and codeine side effects
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, 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.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
noisy breathing, sighing, shallow breathing;
a slow heart rate or weak pulse;
extreme drowsiness, feeling like you might pass out;
chest pain, fast or pounding heart rate, feeling short of breath;
confusion, unusual thoughts or behavior;
liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
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 overweight, malnourished, or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common side effects include:
drowsiness, dizziness, feeling "drunk";
headache, tiredness; or
nausea, vomiting, stomach pain, constipation.
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.
Acetaminophen, butalbital, caffeine, and codeine dosing information
Usual Adult Dose for Headache:
1 or 2 capsules orally every 4 hours as needed not to exceed 6 capsules per day
-Because of the risks of addiction, abuse, and misuse, prescribing should be reserved to patients for whom alternative options have not been tolerated or are not expected to be tolerated; and for patients for whom alternative options have not provided adequate analgesia or are not expected to provide adequate analgesia.
-The safety and efficacy of treating multiple recurrent headaches with this product is not known.
Uses: For the relief of the symptom complex of tension (or muscle contraction) headache when nonopioid analgesic and alternative treatments are inadequate.
What other drugs will affect acetaminophen, butalbital, caffeine, and codeine?
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
other narcotic medications--opioid pain medicine or prescription cough medicine;
drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
This list is not complete. Other drugs may affect acetaminophen, butalbital, caffeine, and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2018 Cerner Multum, Inc. Version: 17.02.
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