codeine-butalbital-ASA-caffeine 30 mg-50 mg-325 mg-40 mg capsule

Generic name:
Codeine/butalbital/aspirin/caffeine - oral

Pronunciation
(KOE-deen/byou-TAL-bih-tall/AS-pir-in/KAF-een)

Brand name(s)
Fiorinal with Codeine #3

Codeine has a risk for abuse and addiction, which can lead to overdose and death. Codeine may also cause severe, possibly fatal, breathing problems. To lower your risk, your doctor should have you take the smallest dose of codeine that works, and take it for the shortest possible time. See also How to Use section for more information about addiction.

Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it.

The risk for severe breathing problems is higher when you start this medication and after a dose increase, or if you take the wrong dose/strength. Taking this medication with alcohol or other drugs that can cause drowsiness or breathing problems may cause very serious side effects, including death. Also, other medications can affect the removal of codeine from your body, which may affect how codeine works. Be sure you know how to take this medication and what other drugs you should avoid taking with it. See also Drug Interactions section. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.

Keep this medicine in a safe place to prevent theft, misuse, or abuse. If someone accidentally swallows this medication, get medical help right away.

Children younger than 18 years should not use products that contain codeine. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). The risk is greater in children who are obese or have breathing problems, or after certain surgeries (including tonsil/adenoid removal). Talk with your doctor or pharmacist about the risks and benefits of this medication.

See also Warning section.

This combination medication is used to treat tension headaches. Codeine is an opioid pain reliever that acts on certain centers in the brain to give you pain relief. Aspirin helps to decrease the pain from the headache. Caffeine helps increase the effects of aspirin. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for migraine headaches.

Read the Medication Guide provided by your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually every 4 hours as needed. Do not take more than 6 capsules in a 24-hour period. Use the smallest effective dose. Take with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. If you have nausea, you may take this medication with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1-2 hours with as little head movement as possible).

The dosage is based on your medical condition, age, and response to treatment. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well.

Do not increase your dose or use this drug more often or for longer than prescribed, because your risk of side effects may increase. Properly stop the medication when so directed.

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, use of this medication for more than 2 headache episodes a week, or if you have any new pain. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

See also Warning section.

Nausea, vomiting, stomach upset, gas, shaking (tremor), constipation, dry mouth, lightheadedness, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• interrupted breathing during sleep (sleep apnea)
• mental/mood changes
• fast/irregular heartbeat
• increased thirst/urination
• hearing changes (such as ringing in the ears)
• easy bruising/bleeding
• heartburn
• discomfort when swallowing
• dark urine
• yellowing eyes/skin
• signs of kidney problems (such as change in the amount of urine)
• signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss)

Get medical help right away if you have any very serious side effects, including:

• fainting
• seizure
• black stools
• severe stomach/abdominal pain
• vomit that looks like coffee grounds
• trouble speaking
• weakness on one side of the body

Codeine is changed into a strong opioid drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following:

• slow/shallow breathing
• severe drowsiness/difficulty waking up
• confusion

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, codeine, or butalbital; or to other barbiturates (such as phenobarbital), salicylates (such as salsalate), nonsteroidal anti-inflammatory drugs (such as ibuprofen), opioid pain medications (such as morphine) or xanthine derivatives (such as theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• asthma (including a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs)
• brain disorders (such as seizures, head injury, tumor, increased intracranial pressure)
• breathing problems (such as chronic obstructive pulmonary disease-COPD, sleep apnea)
• bleeding/blood clotting disorders (such as hemophilia, von Willebrand's disease, thrombocytopenia)
• a certain enzyme disorder (porphyria)
• disease of the pancreas (such as pancreatitis)
• heart disease (such as irregular heartbeat, recent heart attack)
• certain enzyme deficiencies (pyruvate kinase or G6-PD deficiency)
• gout
• liver disease
• kidney disease
• heartburn
• growths in the nose (nasal polyps)
• a certain spinal problem (kyphoscoliosis)
• gallbladder disease
• personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol)
• mental/mood disorders
• stomach/intestinal problems (such as stomach/intestinal ulcers, infectious diarrhea, colitis)
• adrenal gland problem (such as Addison's disease)
• difficulty urinating (such as due to enlarged prostate or urethral stricture)
• underactive thyroid (hypothyroidism)
• recent bowel/abdominal surgery
• obesity

Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Avoid alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness.

Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, slow/shallow breathing, stomach/intestinal bleeding and ulcers, and trouble falling asleep. Confusion, dizziness, drowsiness and trouble falling asleep can increase the risk of falling.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• acetazolamide
• antacids
• certain antibiotics (including penicillin, sulfonamides such as sulfamethoxazole)
• certain drugs used to treat gout (including uricosuric drugs such as probenecid, sulfinpyrazone)
• darunavir
• dichlorphenamide
• lithium
• 6-mercaptopurine
• methotrexate
• methoxyflurane
• mifepristone
• naltrexone
• other medications for pain (such as morphine, nalbuphine, pentazocine)
• samidorphan
• sodium oxybate

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

This drug can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include doxycycline, estrogen, felodipine, lonafarnib, quinidine, rilpivirine, tamoxifen, theophylline, certain beta blockers (such as metoprolol), corticosteroids (such as prednisone), among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as morphine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products, other headache medications) because they may contain aspirin, caffeine or ingredients that cause drowsiness. Certain beverages (such as coffee, colas, tea) may also contain caffeine. Ask your pharmacist about using those products safely.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, NSAIDs such as ibuprofen, ketorolac, naproxen). These drugs are similar to this medication and may increase your risk of side effects if taken together. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of this product from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole), bupropion, fluoxetine, macrolide antibiotics (such as erythromycin), HIV medications (such as ritonavir), paroxetine, rifamycins (such as rifabutin, rifampin), certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

This medication may interfere with certain medical/lab tests (such as fasting blood glucose, cholesterol levels, prothrombin time, urine 5-HIAA levels, amylase and lipase levels, certain urine glucose tests, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, give them naloxone if available, then call 911. If the person is awake and has no symptoms, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: nausea/vomiting that doesn't stop, severe drowsiness, slow/shallow breathing, very small pupils, severe dizziness, ringing in the ears, coma.

Do not share this medication with others. Sharing it is against the law.

Massage, hot baths, and other relaxation methods can help with tension headaches. Consult your doctor or pharmacist for more details.

Lab and/or medical tests (such as liver/kidney function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Not applicable.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.