Do not use Fioricet if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Fioricet before the MAO inhibitor has cleared from your body.

Do not take more Fioricet than is recommended. An overdose of acetaminophen can cause damage to your liver. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together with Fioricet you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) per day.

Before taking this medication, tell your doctor or pharmacist if you are allergic to acetaminophen, caffeine, or butalbital; or to other barbiturates (e.g., phenobarbital) or xanthine derivatives (e.g., theophylline); or if you have any other allergies.

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., bronchopneumonia), a certain enzyme disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, personal or family history of regular use/abuse of drugs/alcohol, mental/mood disorders, abdominal/stomach problems (e.g., stomach ulcer), heart disease (e.g., irregular heartbeat, recent heart attack).

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.

Liquid products may contain alcohol, sugar and/or aspartame. Caution is advised if you have diabetes, alcohol dependence, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.

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.

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

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. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Butalbital may be habit-forming and should be used only by the person it was prescribed for. Fioricet should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not take Fioricet without first talking to your doctor if you drink more than three alcoholic beverages per day or if you have had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

You should not take Fioricet if you are allergic to acetaminophen, butalbital, or caffeine, or if you have porphyria.

Before using Fioricet, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease,
• liver disease; or
• a history of mental illness or suicidal thoughts.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take Fioricet.

FDA pregnancy category C. It is not known whether Fioricet is harmful to an unborn baby. Before taking Fioricet, tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen, butalbital, and caffeine can pass into breast milk and may harm a nursing baby. Do not use Fioricet without telling your doctor if you are breast-feeding a baby.