Generic Name: acetaminophen and butalbital (a SEET a MIN oh fen and bue TAL bi tal)Brand Names: Bupap, Cephadyn, Marten-Tab, Phrenilin, Phrenilin Forte, Promacet, Sedapap
Acetaminophen is a pain reliever and fever reducer.
Butalbital is in a group of drugs called barbiturates. It relaxes muscle contractions involved in a tension headache.
The combination of acetaminophen and butalbital is used to treat tension headaches. This medicine is not for treating headaches that come and go.
Acetaminophen and butalbital may also be used for purposes other than those listed in this medication guide.What is the most important information I should know about Axocet (acetaminophen and butalbital)?
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.
Before you take acetaminophen and butalbital, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease, a stomach or intestinal disorder, or a history of drug or alcohol addiction.Butalbital may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and butalbital 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.
Tell your doctor if the medicine seems to stop working as well in relieving your pain.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. Do not use any other over-the-counter cough, cold, allergy, or pain 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 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 while taking acetaminophen and butalbital. Alcohol may increase your risk of liver damage while taking acetaminophen.What should I discuss with my healthcare provider before taking Axocet (acetaminophen and butalbital)?Do not use this medication if you are allergic to acetaminophen (Tylenol) or butalbital, or if you have porphyria. Butalbital may be habit-forming and should be used only by the person it was prescribed for. This medication should never be given to 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.
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take acetaminophen and butalbital, tell your doctor if you are allergic to any drugs, or if you have:
a stomach or intestinal disorder; or
a history of drug or alcohol addiction.
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.FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it can cause seizures in a newborn if the mother takes the medication late in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and butalbital can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Older adults may be more sensitive to the effects of this medicine.
Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.An overdose of acetaminophen can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day. Take this medicine with a full glass of water. Do not stop using this medication suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
Acetaminophen can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and butalbital.
If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen and butalbital. You may need to stop using the medicine for a short time.Store acetaminophen and butalbital at room temperature away from moisture and heat.
Keep track of how many tablets have been used from each new bottle of this medicine. Butalbital is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.
Since acetaminophen and butalbital is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include loss of appetite, nausea, vomiting, sweating, extreme drowsiness, confusion, fainting, shallow breathing, or no breathing.
fast or pounding heart rate, feeling short of breath;
feeling like you might pass out;
feeling restless, excited, or agitated;
seizure (convulsions); 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:
headache, dizziness, drowsiness, shaky feeling;
heartburn, trouble swallowing;
numbness or tingly feeling;
sweating or urinating more than usual;
leg pain, tired muscles;
stuffy nose, ear pain, ringing in your ears; or
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.
Tell your doctor about all other medications you are using, especially:
an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).
This list is not complete and there may be other drugs that can interact with acetaminophen and butalbital. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.