Brand Names: Fioricet with Codeine, Phrenilin with Caffeine and Codeine

Generic Name: acetaminophen, butalbital, caffeine, and codeine (Pronunciation: a SEET a MIN o fen, bue TAL bi tal, KAF een, and KOE deen)

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

What is acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?

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

Acetaminophen is a less potent pain reliever that increases the effects of codeine.

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.

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

Acetaminophen, butalbital, caffeine, and codeine may also be used for purposes other than those listed in this medication guide.

APAP-Butalbital-Caffeine-Codeine Cap-WAT

blue/white, imprinted with WATSON, 3220

Fioricet with Codeine

blue/peach, imprinted with FIORICET CODEINE, LOGO PROFILES

What are the possible side effects of acetaminophen, butalbital, caffeine, and codeine (Fioricet 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, feeling short of breath;
• feeling light-headed, fainting;
• confusion, unusual thoughts or behavior;
• muscle twitching;
• easy bruising or bleeding; or
• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• feeling dizzy or drowsy, shaky or agitated;
• mild nausea, vomiting, upset stomach, constipation, diarrhea;
• increased appetite;
• mood changes, sleep problems (insomnia);
• sweating, urinating more than usual;
• 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 acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine)?

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

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

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.