Aspirin, butalbital, and caffeine, are
used together in an oral preparation to treat pain, specifically headaches.
Aspirin 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. Fiorinal is also available with codeine.
The combination of aspirin and codeine produces a greater analgesic effect
than that produced by aspirin 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:
Also tell your health care professional if you are allergic
to any other substances, such as foods, preservatives, or dyes.
Tell your doctor if you have ever had
any unusual or allergic reaction to butalbital or other barbiturates;
aspirin or other salicylates, including methyl salicylate (oil of
wintergreen); caffeine; or any of the following medicines:
- Diclofenac (Voltaren)
- Diflunisal (Dolobid)
- Etodolac (Lodine)
- Fenoprofen (Nalfon)
- Floctafenine (Idarac)
- Flurbiprofen, oral (Ansaid)
- Ibuprofen (Motrin, Advil)
- Indomethacin (Indocin)
- Ketoprofen (Orudis)
- Ketorolac (Toradol)
- Meclofenamate (Meclomen)
- Mefenamic acid (Ponstel)
- Nabumetone (Relafen)
- Naproxen (Naprosyn)
- Oxaprozin (Daypro)
- Oxyphenbutazone (Tandearil)
- Phenylbutazone (Butazolidin)
- Piroxicam (Feldene)
- Sulindac (Clinoril)
- Suprofen (Suprol)
- Tenoxicam (Mobiflex)
- Tiaprofenic acid (Surgam)
- Tolmetin (Tolectin)
- Zomepirac (Zomax
FDA pregnancy category C. This means that it is not known whether
aspirin/butalbital/caffeine will harm an unborn baby. Do not take this
medication without first talking to your doctor if you are pregnant.
Aspirin/butalbital/caffeine 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.
Do not use aspirin/butalbital/caffeine to treat a child or teenager
who has a fever, flu symptoms, or chicken pox without first talking to a
doctor. In children younger than 18 years of age, aspirin may increase
the risk of Reye's syndrome, a rare but often fatal condition.
If you are older than 60 years of age, you may be more likely to
experience side effects from this medication. Use extra caution.
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.
- Do not take
aspirin/butalbital/caffeine if you have taken a monoamine oxidase
inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil),
or tranylcypromine (Parnate) in the last 14 days. Dangerous sedation
- Aspirin/butalbital/caffeine may
increase the effects of other drugs that cause drowsiness, including
antidepressants, alcohol, antihistamines, sedatives (used to treat
insomnia), pain relievers, anxiety medicines, and muscle relaxants.
Tell your doctor about all medicines that you are taking, and do not
take any medicine unless your doctor approves.
- Dangerous side effects may occur if
aspirin is taken with any of the following medicines:
- oral anticoagulants such as
- probenecid (Benemid) or
- nonsteroidal anti-inflammatory
drugs (NSAIDs) such as ibuprofen (Motrin, Advil, Nuprin, others),
ketoprofen (Orudis, Orudis KT, Oruvail), and naproxen (Naprosyn,
- other salicylates (forms of
aspirin) such as choline salicylate and magnesium salicylate
- steroids such as prednisone (Deltasone),
prednisolone (Prelone, Pediapred, others), methylprednisolone (Medrol,
others), dexamethasone (Decadron), and others
- insulin and oral antidiabetic
drugs such as glipizide (Glucotrol) and glyburide (Micronase,
- Do not take this medication without
first talking to your doctor if you are taking any of the medications
- Many other medicines contain
aspirin, especially over-the-counter pain, fever, cold, and allergy
medications. Too much aspirin can be very dangerous.
- Drugs other than those listed here
may also interact with aspirin/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:
- uncontrolled high blood pressure
- kidney disease
- liver disease
- asthma or another respiratory
- fluid retention
- congestive heart disease or another
type of heart disease
Do not take aspirin/butalbital/caffeine
without first talking to your doctor if you drink more than three
alcoholic beverages per day, if you have a stomach ulcer, if you have a
bleeding or platelet disorder, or if you have recently had surgery.
Proper Use of This Medicine
- Take aspirin/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
- Take each dose with a full glass of
- Take aspirin/butalbital/caffeine
with food or milk if it upsets your stomach.
- Never take more of this medication
than is prescribed for you. Too much aspirin/butalbital/caffeine could
be very harmful. Never take more than six tablets or capsules per day.
- Do not share this medication with
- Do not take this drug if it begins
to smell strongly of vinegar. This smell means that the aspirin in it
is beginning to break down.
- Avoid alcohol. Alcohol taken during
therapy with aspirin/butalbital/caffeine can increase the risk of
stomach bleeding 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 Fiorinal 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. You should not take more than six 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 labels of all
nonprescription (over-the-counter [OTC]) and prescription medicines
you now take. If any contain a barbiturate, aspirin, or other
salicylates, including diflunisal, check with your health care
- 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 aspirin. 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
- Do not take this medicine for 5 days
before any planned surgery, including dental surgery, unless otherwise
directed by your medical doctor or dentist. Taking aspirin during this
time may cause bleeding problems.
- Before you have any medical tests,
tell the person in charge that you are taking this medicine. Caffeine
(present in some butalbital and aspirin 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 aspirin
- 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
The following side effects may mean
that a serious allergic reaction is occurring. Check with your doctor or
get emergency help immediately if they occur, especially if several of
them occur at the same time.
- Less common or rare: Bluish
discoloration or flushing or redness of skin (occurring together with
other effects listed in this section); coughing, shortness of breath,
troubled breathing, tightness in chest, or wheezing; difficulty in
swallowing; dizziness or feeling faint (severe); hive-like swellings
(large) on eyelids, face, lips, or tongue; skin rash, itching, or
hives; stuffy nose (occurring together with other effects listed in
Also check with your doctor immediately
if any of the following side effects occur, especially if several of
them occur together:
- Rare: Bleeding or crusting sores on
lips; chest pain; fever with or without chills; red, thickened, or
scaly skin; sores, ulcers, or white spots in mouth (painful); sore
throat (unexplained); tenderness, burning, or peeling of skin
Also, check with your doctor as soon as
possible if any of the following side effects occur:
- Less common or rare: Bloody or
black, tarry stools; bloody urine; confusion or mental depression;
muscle cramps or pain; pinpoint red spots on skin; swollen or painful
glands; unusual bleeding or bruising; unusual excitement (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);
heartburn or indigestion; nausea, vomiting, or stomach pain (occurring
without other symptoms of overdose)
Some commonly used brand names are:
In the U.S.-