Acetaminophen, butalbital, and
caffeine, are used together in an oral preparation to treat pain,
specifically headaches. Acetaminophen is a non-narcotic analgesic for
pain and headache relief. Butalbital is a barbiturate used for its
sedative effects. Caffeine is found in many analgesic formulations and
may be beneficial in Migraine and vascular headaches. Fioricet is also
available with codeine. The combination of
acetaminophen and codeine produces a greater analgesic effect than that
produced by acetaminophen alone or by higher doses of opiate. Also, this
combination might cause fewer adverse reactions than do equianalgesic
doses of either agent alone.
Before Using This Medicine
In deciding to use a medicine, the risks
of taking the medicine must be weighed against the good it will do. This
is a decision you and your doctor will make. For frovatriptan, the
following should be considered:
Be certain to tell your doctor if you have ever had any
unusual or allergic reaction to butalbital or other barbiturates, or to
acetaminophen, aspirin, or caffeine. Also tell your health care
professional if you are allergic to any other substances, such as foods,
preservatives, or dyes.
FDA pregnancy category C. This means that its effects on an unborn
baby are not known. Do not take this medication without first talking to
your doctor if you are pregnant.
This drug combination passes into breast milk and may harm a nursing
infant. Do not take this medication without first talking to your doctor
if you are breast-feeding a baby.
- For butalbital: Although
barbiturates such as butalbital often cause drowsiness, some children
become excited after taking them.
- For acetaminophen: Acetaminophen has
been tested in children and, in effective doses, has not been shown to
cause different side effects or problems than it does in adults.
- For caffeine: There is no specific
information comparing use of caffeine in children up to 12 years of
age with use in other age groups. However, caffeine is not expected to
cause different side effects or problems in children than it does in
- For butalbital: Certain side
effects, such as confusion, excitement, or mental depression, may be
especially likely to occur in elderly patients, who are usually more
sensitive than younger adults to the effects of the butalbital in this
- For acetaminophen: Acetaminophen has
been tested and has not been shown to cause different side effects or
problems in older people than it does in younger adults.
- For caffeine: Many medicines have
not been studied specifically in older people. Therefore, it may not
be known whether they work exactly the same way they do in younger
adults or if they cause different side effects or problems in older
people. There is no specific information comparing use of caffeine in
the elderly with use in other age groups.
Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur. In
these cases, your doctor may want to change the dose, or other
precautions may be necessary. It is especially important to tell your
doctor if you are taking:
- Anticoagulants (blood thinners)
- Carbamazepine (Tegretol)
- Contraceptives containing estrogen
- Corticosteroids (cortisone-like
- Corticotropin (ACTH)
- Tricyclic Antidepressants
- Central nervous system (CNS)
depressants (medicines that often cause drowsiness)
- Divalproex (Depakote) or Valproic
- Drugs other than those listed here
may also interact with Acetaminophen/butalbital/caffeine. Talk to your
doctor and pharmacist before taking any prescription or
Other medical problems-
The presence of other medical
problems may affect the use of frovatriptan. Make sure you tell your
doctor if you have any other medical problems, especially:
- alcohol abuse (or history of)
- drug abuse or dependence (or history
- Asthma, emphysema, or other chronic
- hepatitis or other liver disease
- typeractivity (in children)
- kidney disease
- diabetes mellitus
- mental depression
- overactive thyroid
- porphyria (or history of)
- heart disease (severe)
Proper Use of This Medicine
Acetaminophen/butalbital/caffeine exactly as directed by your doctor.
If you do not understand these directions, ask your pharmacist, nurse,
or doctor to explain them to you.
- Take each dose with a full glass of
Acetaminophen/butalbital/caffeine with food or milk if it upsets your
- Never take more of this medication
than is prescribed for you. Too much Acetaminophen/butalbital/caffeine
could be very harmful. Never take more than six tablets or capsules
- Do not share this medication with
- Avoid alcohol. Alcohol taken during
therapy with acetaminophen and butalbital can be very damaging to your
liver and can increase drowsiness and dizziness.
- This medicine will relieve a head
pain best if you take it as soon as the pain begins. If you get
warning signs of a migraine, take this medicine as soon as you are
sure that the migraine is coming. This may even stop the head pain
from occurring. Lying down in a quiet, dark room for a while after
taking the medicine also helps to relieve head pain.
- People who who have frequent head
pain episodes may need to take a different medicine to help prevent
headaches or Migraines. It is important that you follow your doctor's
directions about taking the other medicine, even if your headaches or
Migraines continue to occur. Preventive medicines may take several
weeks to start working. Even after they do start working, your
headaches or Migraines may not go away completely. However, they
should occur less often, and should be less severe and easier to
relieve than before.
The dose of Fioricet will be different for different
patients. Follow your doctor's orders or the directions on the label.
The following information includes only the average doses.
If your dose is different, do not change it unless your doctor
tells you to do so.
- AdultsóOne or 2 capsules or tablets
every four hours as needed. If your medicine contains 325 or 500
milligrams (mg) of acetaminophen in each capsule or tablet, you should
not take more than six capsules or tablets a day. If your medicine
contains 650 mg of acetaminophen in each capsule or tablet, you should
not take more than four capsules or tablets a day.
- ChildrenóDose must be determined by
To store this medicine:
- Keep out of the reach of children
since overdose is especially dangerous in children.
- Store away from heat and direct
- Do not store in the bathroom, near
the kitchen sink, or in other damp places. Heat or moisture may cause
the medicine to break down.
- Do not keep outdated medicine or
medicine no longer needed. Be sure that any discarded medicine is out
of the reach of children.
Precautions While Using This Medicine
Check with your doctor if the medicine
stops working as well as it did when you first started using it. This
may mean that you are in danger of becoming dependent on the medicine.
Do not try to get better pain relief by increasing the dose.
- Check with your doctor if you are
having headaches or Migraines more often than you did before you
started using this medicine. This is especially important if a new
episode occurs within 1 day after you took your last dose of medicine,
episodes begin to occur every day, or an episode continues for several
days in a row. This may mean that you are dependent on the headache
medicine. Continuing to take this medicine will cause even more
headaches later on. Your doctor can give you advice on relief.
- Check the acetaminophen content of
other over-the-counter and prescription products while taking this
medication. You should not exceed 4 grams (4000 mg) of acetaminophen
- The butalbital in this medicine will
add to the effects of alcohol and other CNS depressants (medicines
that slow down the nervous system, possibly causing drowsiness). Some
examples of CNS depressants are antihistamines or medicine for hay
fever, other allergies, or colds; sedatives, tranquilizers, or
sleeping medicine; other prescription pain medicine or narcotics;
other barbiturates; medicine for seizures; muscle relaxants; or
anesthetics, including some dental anesthetics. Also, stomach problems
may be more likely to occur if you drink alcoholic beverages while you
are taking Acetaminophen. Therefore, do not drink alcoholic beverages,
and check with your doctor before taking any of the medicines listed
above, while you are using this medicine.
- This medicine may cause some people
to become drowsy, dizzy, or lightheaded. Make sure you know how you
react to this medicine before you drive, use machines, or do anything
else that could be dangerous if you are dizzy or are not alert and
- Before having any kind of surgery
(including dental surgery) or emergency treatment, tell the medical
doctor or dentist in charge that you are taking this medicine. Serious
side effects may occur if your medical doctor or dentist gives you
certain other medicines without knowing that you have taken
- Before you have any medical tests,
tell the person in charge that you are taking this medicine. Caffeine
(present in some butalbital and Acetaminophen combinations) interferes
with the results of certain tests that use dipyridamole (e.g.,
Persantine) to help show how well blood is flowing to your heart.
Caffeine should not be taken for 8 to 12 hours before the test. The
results of some other tests may also be affected by butalbital and
- If you have been taking large
amounts of this medicine, or if you have been taking it regularly for
several weeks or more, do not suddenly stop using it without first
checking with your doctor. Your doctor may want you to reduce
gradually the amount you are taking before stopping completely, to
lessen the chance of withdrawal side effects.
- If you think you or anyone else may
have taken an overdose of this medicine, get emergency help at once.
Side Effects of This Medicine
Along with its needed effects,
a medicine may cause some unwanted effects. Although not all of these
side effects may occur, if they do occur they may need medical
Check with your doctor immediately if
any of the following side effects occur, especially if several of them
- Rare: Bleeding or crusting sores on
lips; chest pain; fever with or without chills; hive-like swellings
(large) on eyelids, face, lips, and/or tongue; muscle cramps or pain;
red, thickened, or scaly skin; shortness of breath, troubled
breathing, tightness in chest, or wheezing; skin rash, itching, or
hives; sores, ulcers, or white spots in mouth (painful); sore throat
Also, check with your doctor as soon as
possible if any of the following side effects occur:
- Less comon: confusion (mild); mental
depression; unusual excitement (mild)
- Rare: bloody or black, tarry stools;
bloody urine; pinpoint red spots on skin; swollen or painful glands;
unusual bleeding or bruising ; unusual tiredness or weakness (mild)
Other side effects may occur that
usually do not need medical attention. These side effects may go away
during treatment as your body adjusts to the medicine. However, check
with your doctor if any of the following side effects continue or are
- More common: Bloated or "gassy'"
feeling; dizziness or lightheadedness (mild); drowsiness (mild);
nausea, vomiting, or stomach pain
Some commonly used brand names are:
In the U.S.-
not commercially available