Fiorinal with Codeine is a combination medicine used to treat tension headaches after other treatments have failed. Fiorinal with Codeine 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.

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.

Follow the directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share this 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.

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.

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. 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, mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag throw the bag in the trash.

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.

Since Fiorinal with 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.

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 symptoms may include extreme drowsiness, confusion, muscle weakness, fast or slow heartbeats, restlessness, tremor, dilated or pinpoint pupils, ringing in your ears, feeling hot, vomiting, fainting, blue lips, cold and clammy skin, very slow breathing, seizure, or coma.

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).

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.

Fiorinal with Codeine may cause serious side effects. 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.

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");

• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;

• other narcotic medications--opioid pain medicine or prescription cough medicine;

• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;

• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or

• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect Fiorinal with Codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.