Aspirin Butalbital Caffeine Codeine

Aspirin, Butalbital, Caffeine, and Codeine is a combination medication used to treat tension headaches after other treatments have failed. 

• Aspirin, Butalbital, Caffeine, and Codeine are available under various brand names: Ascomp with Codeine, Fiorinal with Codeine, Fiortal with Codeine 

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

• nausea, vomiting, 
• stomach pain, constipation.
• headache, dizziness, drowsiness; or
• feeling tired.

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

hives. 

• difficult breathing. 
• swelling of the face, lips, tongue, or throat.
• noisy breathing, sighing, shallow breathing, breathing that stops during sleep.
• a slow heart rate or weak pulse.
• a light-headed feeling, like you, might pass out.
• confusion, unusual thoughts, or behavior.
• easy bruising or bleeding (nosebleeds, bleeding gums);
• severe constipation.
• symptoms of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
• agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
• impaired fertility in men or women.

Rare side effects of Aspirin, 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 such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, 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

• 50 mg/325 mg/40 mg/30 mg

Tension or muscle contraction headache: 

Adult and pediatric dosage

• Oral: 1 to 2 capsules (butalbital 50 mg/aspirin 325 mg/caffeine 40 mg/codeine 30 mg) every 4 hours as needed.
• maximum: 6 capsules (butalbital 300 mg/aspirin 1,950 mg/caffeine 240 mg/codeine 180 mg) 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.

• Aspirin, Butalbital, Caffeine, and Codeine have severe interactions with the following drugs:
  • abrocitinib
  • alvimopan
  • dichlorphenamide
  • doravirine
  • isocarboxazid
  • linezolid
  • mifepristone
  • phenelzine
• Aspirin, Butalbital, Caffeine, and Codeine have serious interactions with at least 97 other drugs.
• Aspirin, Butalbital, Caffeine, and Codeine have moderate interactions with at least 691 other drugs.
• Aspirin, Butalbital, Caffeine, and Codeine have minor interactions with at least 268 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

• Hypersensitivity to aspirin, butalbital, caffeine, or codeine.
• severe asthma, asthma with a runny nose and nasal polyps, or other breathing problems.
• a stomach or bowel obstruction (including paralytic ileus).
• an allergy to NSAIDs (nonsteroidal anti-inflammatory drugs).
• hemophilia; or
• if you have used an MAO inhibitor in the past 14 days (such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine).
• Children younger than 12 years old.
• Anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.
• Do not give this medicine to a teenager with a fever, flu symptoms, or chickenpox. Aspirin can cause Reye's syndrome, a serious and sometimes fatal condition in adolescents.

Effects of drug abuse

• Addiction, 
• Overdose, or 
• Death

Short-Term Effects

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

Long-Term Effects

• See “What Are Side Effects Associated with Using Aspirin, 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 this 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.
• Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
• Do not drink alcohol. Dangerous side effects or death could occur.
• Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to aspirin (such as ibuprofen, ketoprofen, or naproxen).

Pregnancy and 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.
• Taking aspirin during late pregnancy may cause bleeding in the mother or the baby during delivery.
• Lactation
  • Do not breastfeed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.