Acetaminophen (a-seet-a-MIN-oh-fen), Butalbital (bue-TAL-bi-tal), Caffeine (KAF-een), Codeine Phosphate (KOE-deen FOS-fate)

Treats headaches. This medicine contains a narcotic pain reliever.

Brand Name(s):

Fioricet with Codeine

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone and other medicines to treat an overdose.
• This medicine contains acetaminophen. Read the labels of all other medicines you are using to see if they also contain acetaminophen, or ask your doctor or pharmacist. Do not use more than 4 grams (4,000 milligrams) total of acetaminophen in one day.
• This medicine is not for long-term use.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in a safe and secure place. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA website for locations. Here is the link to the FDA safe disposal of medicines web site: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  • Amiodarone, bupropion, carbamazepine, erythromycin, fluoxetine, ketoconazole, mirtazapine, paroxetine, phenytoin, quinidine, rifampin, ritonavir, tramadol, trazodone
  • Benzodiazepine medicine
  • Diuretic (water pill)
  • Medicine to treat anxiety, depression, or mental health problems (including SNRIs, SSRIs, TCAs)
  • Phenothiazine medicine
  • Triptan medicine to treat migraine headaches
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer (including cyclobenzaprine, metaxalone).
• Do not drink alcohol while you are using this medicine. Acetaminophen can damage your liver, and alcohol can increase this risk.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, lung or breathing problems (including COPD, sleep apnea), Addison disease, diabetes, an enlarged prostate, trouble urinating, gallbladder problems, pancreas problems, an underactive thyroid, or stomach problems. Tell your doctor if you have a history of brain tumor, head injury, depression, seizures, or drug or alcohol addiction.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Adrenal gland problem
  • Low blood pressure
  • Liver damage
  • Worsening of pain
  • Serious skin reactions (including acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • Serotonin syndrome (when used with certain medicines)
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Blue lips, fingernails, or skin
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Extreme dizziness or weakness, trouble breathing, slow heartbeat, seizures, and cold, clammy skin
• Severe confusion, lightheadedness, dizziness, fainting
• Severe constipation or stomach pain
• Shaking, trembling, hunger
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Sleepiness, tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088