Brand Names: Fiorinal with Codeine

Generic Name: aspirin, butalbital, caffeine, and codeine (Pronunciation: AS pir in, bue TAL bi tal, KAF een, and KOE deen)

• What is aspirin, butalbital, caffeine, and codeine (Fiorinal with Codeine)?
• What are the possible side effects of aspirin, butalbital, caffeine, and codeine (Fiorinal with Codeine)?
• What is the most important information I should know about aspirin, butalbital, caffeine, and codeine (Fiorinal with Codeine)?
• What should I discuss with my healthcare provider before taking aspirin, butalbital, caffeine, and codeine (Fiorinal with Codeine)?
• How should I take aspirin, butalbital, caffeine, and codeine (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, and codeine (Fiorinal with Codeine)?
• What other drugs will affect aspirin, butalbital, caffeine, and codeine (Fiorinal with Codeine)?
• Where can I get more information?

What is aspirin, butalbital, caffeine, and codeine (Fiorinal with Codeine)?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.

Caffeine is a central nervous system stimulant. It relaxes muscle contractions in blood vessels to improve blood flow.

Codeine is in a group of drugs called narcotic pain relievers.

The combination of aspirin, butalbital, caffeine, and codeine is used to treat tension headaches. This medicine is not for treating headaches that come and go.

This medication may also be used for purposes other than those listed in this medication guide.

Fiorinal 3

blue/yellow, imprinted with S F-C, SANDOZ 78-107

Fiorinal Codeine-WAT

blue/yellow, imprinted with FIORINAL CODEINE, WATSON 956

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 grounds;
• problems with urination; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• feeling dizzy, shaky, anxious, or agitated;
• heartburn, mild nausea, vomiting, upset stomach, constipation, diarrhea;
• mood changes, sleep problems (insomnia);
• sweating, urinating more than usual; or
• ringing in your ears, blurred vision, or dry mouth.

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 report side effects to FDA at 1-800-FDA-1088.

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

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Codeine and butalbital may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it.