Fiorinal with Codeine

DRUG DESCRIPTION

Fiorinal® with Codeine (Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, USP) is supplied in capsule form for oral administration.

Each capsule contains the following active ingredients:

butalbital, USP ............................. 50 mg
aspirin, USP ............................... 325 mg
caffeine, USP ............................... 40 mg
codeine phosphate, USP . .. .. . . .30 mg

Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula:

Butalbital structural formula illustration

C11H16N2O3.............molecular weight 224.26

Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula:

Aspirin structural formula illustration

C9H8O4.............molecular weight 180.16

Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula:

Caffeine structural formula illustration

C8H10N4O2...................molecular weight 194.19

Codeine phosphate (7,8-Didehydro-4,5?-epoxy-3-methoxy-17-methylmorphinan-6?-ol phosphate (1:1) (salt) hemihydrate) is a narcotic analgesic and antitussive. It has the following structural formula:

Codeine phosphate structural formula illustration

C18H24NO7P.......................anhydrous molecular weight 397.37

Inactive Ingredients

microcrystalline cellulose, pregelatinized starch, talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, titanium dioxide. The capsules are printed with edible ink containing red iron oxide.

What are the possible side effects of aspirin, butalbital, caffeine, and codeine (Fiorinal with Codeine)?

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

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heart rate;
  • fast or pounding heart rate, muscle twitching;
  • confusion, unusual thoughts or behavior;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee...

Read All Potential Side Effects and See Pictures of Fiorinal with Codeine »

What are the precautions when taking butalbital compound with codeine (Fiorinal with Codeine)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, or butalbital; or to other barbiturates (e.g., phenobarbital), salicylates (e.g., salsalate), nonsteroidal anti-inflammatory drugs (e.g., ibuprofen), or xanthine derivatives (e.g., 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., bronchopneumonia), a certain enzyme disorder (porphyria), aspirin-sensitive asthma (a history of worsening breathing with...

Read All Potential Precautions of Fiorinal with Codeine »


Fiorinal with Codeine Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, stomach upset, gas, shaking (tremor), lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: mental/mood changes, fainting, fast/irregular heartbeat, increased thirst/urination, hearing changes (e.g., ringing in the ears), easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), heartburn, discomfort when swallowing, dark urine, yellowing eyes/skin, change in the amount of urine, unusual tiredness.

Seek immediate medical attention if any of these rare but very serious side effects occur: black stools, severe stomach/abdominal pain, vomit that looks like coffee grounds, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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.

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

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, or butalbital; or to other barbiturates (e.g., phenobarbital), salicylates (e.g., salsalate), nonsteroidal anti-inflammatory drugs (e.g., ibuprofen), or xanthine derivatives (e.g., 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., bronchopneumonia), a certain enzyme disorder (porphyria), aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), severe stomach/bowel problems (e.g., stomach/intestinal ulcers), bleeding/blood clotting disorders (e.g., hemophilia, von Willebrand's disease, thrombocytopenia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, asthma, heartburn, gout, growths in the nose (nasal polyps), personal or family history of regular use/abuse of drugs/alcohol, certain enzyme deficiencies (pyruvate kinase or G6-PD deficiency), mental/mood disorders, heart disease (e.g., irregular heartbeat, recent heart attack).

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

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. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

This medication contains aspirin. Children and teenagers 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.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.

This medication is not recommended for use during pregnancy. Consult your doctor for more details.

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


Fiorinal with Codeine Patient Information Including Side Effects

Brand Names: Fiorinal, Fiormor, Fiortal, Fortabs, Laniroif

Generic Name: aspirin/butalbital/caffeine (Pronunciation: AS pir in/byoo TAL bi tall/CAF een)

  • What is aspirin/butalbital/caffeine (Fiorinal with Codeine)?
  • What are the possible side effects of aspirin/butalbital/caffeine (Fiorinal with Codeine)?
  • What is the most important information I should know about aspirin/butalbital/caffeine (Fiorinal with Codeine)?
  • What should I discuss with my healthcare provider before taking aspirin/butalbital/caffeine (Fiorinal with Codeine)?
  • How should I take aspirin/butalbital/caffeine (Fiorinal with Codeine)?
  • What happens if I miss a dose (Fiorinal with Codeine)?
  • What happens if I overdose (Fiorinal with Codeine)?
  • What should I avoid while taking aspirin/butalbital/caffeine (Fiorinal with Codeine)?
  • What other drugs will affect aspirin/butalbital/caffeine (Fiorinal with Codeine)?
  • Where can I get more information?

What is aspirin/butalbital/caffeine (Fiorinal with Codeine)?

Aspirin is a pain reliever, as well as an anti-inflammatory and a fever reducer.

Butalbital is in a class of drugs called barbiturates that slow down your central nervous system (brain and nerve impulses) and cause relaxation.

Caffeine is believed to constrict dilated blood vessels (veins and arteries) that may contribute to tension headaches.

Aspirin/butalbital/caffeine is used to relieve complex tension headaches, although precisely how it works is unknown.

Aspirin/butalbital/caffeine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of aspirin/butalbital/caffeine (Fiorinal with Codeine)?

If you experience any of the following serious side effects, stop taking aspirin/butalbital/caffeine and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • slow, weak breathing;
  • severe weakness or dizziness; or
  • black, bloody, or tarry stools or blood in your urine or vomit.

Other, less serious side effects may be more likely to occur. Continue to take aspirin/butalbital/caffeine and talk to your doctor if you experience

  • dry mouth, nausea, vomiting, or decreased appetite;
  • dizziness, tiredness, or lightheadedness; or
  • ringing in your ears.

Butalbital may be habit forming.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about aspirin/butalbital/caffeine (Fiorinal with Codeine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Butalbital may cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.

Avoid alcohol. Alcohol taken during therapy with aspirin/butalbital/caffeine can increase the risk of stomach bleeding and can increase drowsiness and dizziness.

Never take more aspirin/butalbital/caffeine than is prescribed for you. If your pain is not being adequately treated, talk to your doctor.

Avoid other over-the-counter and prescription products that contain aspirin. Too much aspirin could be dangerous. Talk to your doctor or pharmacist before taking any over-the-counter preparations.

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