Aspirin, butalbital, caffeine, and codeine is a combination medicine used to treat tension headaches after other treatments have failed. This medicine is not for treating headaches that come and go.

This medicine contains codeine, an opioid (narcotic) medicine, and may be habit-forming.

This medication may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to aspirin, butalbital, caffeine, or codeine, or if you have:

• severe asthma, asthma with 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).

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:

• sleep apnea or other breathing disorders;
• a stomach ulcer or bowel obstruction;
• a vitamin K deficiency;
• seizures, head injury, or brain tumor;
• liver or kidney disease;
• alcoholism or a drug addiction;
• problems with your pancreas, thyroid, or gallbladder.
• urination problems; or
• if you take medicine to treat or prevent blood clots (such as warfarin, enoxaparin, clopidogrel, rivaroxaban, Coumadin, Effient, or Xarelto).

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.

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.

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

Use Fiortal With Codeine (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

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, 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.

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.

Common side effects include:

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

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).