Acetaminophen Butalbital Caffeine Codeine

Acetaminophen, Butalbital, Caffeine, and Codeine are combination prescription medications used for treating tension headaches.

• Acetaminophen, Butalbital, Caffeine, and Codeine are available under various brand names: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

Common side effects of Acetaminophen, Butalbital, Caffeine, and Codeine include:

• drowsiness, dizziness, feeling "drunk";
• headache, tiredness; or
• nausea, vomiting, stomach pain, constipation.

Serious side effects of Acetaminophen, Butalbital, Caffeine, and Codeine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe skin rash,
• severe headache, 
• 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;
• high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea;
• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• liver problems--nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Rare side effects of Acetaminophen, Butalbital, Caffeine, and Codeine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule: Schedule III

• 30 mg/325 mg/50 mg/40 mg
• 30 mg/300 mg/50 mg/40 mg

Tension Headache

Adult dosage

• 1-2 tab/cap orally every 4 hours; not to exceed 6 tab/cap per day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Acetaminophen, Butalbital, Caffeine, and Codeine have severe interactions with the following drugs:
  • alvimopan
  • doravirine
  • isocarboxazid
• Acetaminophen, Butalbital, Caffeine, and Codeine have serious interactions with at least 84 other drugs.
• Acetaminophen, Butalbital, Caffeine, and Codeine have moderate interactions with at least 456 other drugs.
• Acetaminophen, Butalbital, Caffeine, and Codeine have minor interactions with at least 204 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Allergic to acetaminophen, butalbital, caffeine, or codeine
• Severe asthma or breathing problems;
• A blockage in your stomach or intestines;
• 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.

Effects of drug abuse

• addiction,
• overdose, or
• death

Short-Term Effects

• See “What Are Side Effects Associated with Using Acetaminophen, Butalbital, Caffeine, and Codeine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Acetaminophen, Butalbital, Caffeine, and Codeine?”

Cautions

• 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.
• 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.

Pregnancy & Lactation

• 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.
• Lactation
  • Do not breastfeed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.