Fioricet with Codeine

DRUG DESCRIPTION

Fioricet with Codeine (Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate) is supplied in capsule form for oral administration.

Each capsule contains the following active ingredients:

butalbital, USP........................50 mg
acetaminophen, 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

Acetaminophen (4'-hydroxyacetanilide) is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:


C8H9NO2 molecular weight 151.16

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


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:


C18H24NO7P anhydrous molecular weight 397.37

Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch. Gelatin capsules contain black iron oxide, D&C Red No. 33, FD&C Blue No. 1, gelatin, red iron oxide, and titanium dioxide. The capsules are printed with edible inks containing D&C Red No. 7 Calcium Lake, FD&C Blue No. 1 Aluminum Lake, and titanium dioxide.

What are the possible side effects of acetaminophen, butalbital, caffeine, and codeine (Fioricet with Codeine, Phrenilin with Caffeine and 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;
  • ...

Read All Potential Side Effects and See Pictures of Fioricet with Codeine

What are the precautions when taking butalbital, acetaminophen, caffeine and codeine phosphate capsule (Fioricet with Codeine)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, codeine, or butalbital; or to other barbiturates (e.g., phenobarbital), xanthine derivatives (e.g., theophylline) or narcotic pain medications (e.g., morphine); 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., respiratory depression, hypercarbia, bronchopneumonia), infectious diarrhea, a certain enzyme disorder (porphyria), intoxication with medications that...

Read All Potential Precautions of Fioricet with Codeine


Fioricet with Codeine Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, abdominal pain, shaking (tremor), shortness of breath, constipation, dry mouth, 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.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

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, seizure, fast/irregular heartbeat, increased thirst/urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: slow/shallow breathing, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, change in the amount of urine.

If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: persistent nausea/vomiting, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, extreme tiredness.

If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication.

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 acetaminophen, caffeine, codeine, or butalbital; or to other barbiturates (e.g., phenobarbital), xanthine derivatives (e.g., theophylline) or narcotic pain medications (e.g., morphine); 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., respiratory depression, hypercarbia, bronchopneumonia), infectious diarrhea, a certain enzyme disorder (porphyria), intoxication with medications that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), lung diseases (e.g., chronic obstructive pulmonary disease-COPD, asthma, hypoxia, hypercapnia), disease of the pancreas (e.g., pancreatitis), heart disease (e.g., irregular heartbeat, recent heart attack), liver disease, kidney disease, a certain spinal problem (kyphoscoliosis), gallbladder disease, personal or family history of regular use/abuse of drugs/alcohol, mental/mood disorders, abdominal/stomach problems (e.g., stomach ulcer, colitis), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., due to enlarged prostate or urethral stricture), underactive thyroid (hypothyroidism), recent bowel/abdominal surgery.

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.

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

This product contains acetaminophen, which may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Avoid alcohol. Check with your doctor or pharmacist for more information.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, seizures, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Fioricet with Codeine Patient Information Including Side Effects

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.

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.

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