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Medications and Drugs

Brand Names: Ascomp with Codeine, 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 (Ascomp with Codeine, Fiorinal with Codeine)?

Aspirin is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation.

Butalbital is a barbiturate. 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 an opioid pain medication. An opioid is sometimes called a narcotic.

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 not listed in this medication guide.

Fiorinal 3

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

Fiorinal Codeine-WAT

capsule, blue/yellow, imprinted with FIORINAL CODEINE, WATSON 956

What are the possible side effects of this medication (Ascomp with Codeine, Fiorinal with Codeine)?

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • shallow breathing, slow heart rate;
  • fast or pounding heart rate, muscle twitching;
  • confusion, unusual thoughts or behavior;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • problems with urination; or
  • nausea, upper stomach pain, itching, 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 this medication (Ascomp with 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 for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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