Description
Butalbital, aspirin, and caffeine combination is used to relieve symptoms of tension (or muscle contraction) headaches. Extended and repeated use of this product is not recommended.
Butalbital belongs to the group of medicines called barbiturates. Barbiturates act in the central nervous system (CNS) to produce their effects.
Aspirin is used to relieve pain and reduce fever in patients. It belongs to the group of medicines known as salicylates and acts on the immune system to reduce inflammation. It is also known as an anti-inflammatory analgesic.
Caffeine is a CNS stimulant that is used with pain relievers to increase their effect. It has also been used for migraine headaches. Codeine belongs to the group of medicine called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
When butalbital is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects when you suddenly stop taking the medicine. In patients who get headaches, the first symptom of withdrawal may be new (rebound) headaches.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
- Tablet
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of butalbital, aspirin, and caffeine combination in the pediatric population. Safety and efficacy have not been established.
Geriatric
No information is available on the relationship of age to the effects of butalbital, aspirin, and caffeine combination in geriatric patients. Elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Abrocitinib
- Defibrotide
- Dichlorphenamide
- Influenza Virus Vaccine, Live
- Ketorolac
- Riociguat
- Viloxazine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acarbose
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Acepromazine
- Acetazolamide
- Alclometasone
- Aldosterone
- Alfentanil
- Alipogene Tiparvovec
- Alprazolam
- Alteplase, Recombinant
- Amcinonide
- Amikacin
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphotericin B
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Anisindione
- Apixaban
- Aprobarbital
- Ardeparin
- Argatroban
- Aripiprazole
- Aripiprazole Lauroxil
- Asenapine
- Bacitracin
- Baclofen
- Beclomethasone
- Bemetizide
- Bemiparin
- Benazepril
- Bendroflumethiazide
- Benperidol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Atenolol
- Betaxolol
- Bisoprolol
- Carteolol
- Carvedilol
- Celiprolol
- Delapril
- Esmolol
- Imidapril
- Labetalol
- Levobunolol
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Nitroglycerin
- Ospemifene
- Oxprenolol
- Penbutolol
- Pindolol
- Prednisone
- Probenecid
- Propranolol
- Sotalol
- St John's Wort
- Streptokinase
- Tamarind
- Temocapril
- Tenecteplase
- Timolol
- Warfarin
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Tobacco
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison's disease (an adrenal problem) or
- Alcohol or drug abuse or dependence, or history of or
- Brain tumor, history of, or
- Breathing problems (eg, asthma) or
- Enlarged prostate or
- Head injury, or history of or
- Hypothyroidism (underactive thyroid) or
- Increased pressure in the head or
- Reye's syndrome or
- Stomach or digestion problems or
- Trouble urinating—Use with caution. May increase risk for more serious side effects.
- Asthma with nasal polyps, history of or
- Hemophilia (bleeding problem) or
- Hypoprothrombinemia (low prothrombin in the blood) or
- Liver damage, severe or
- Porphyria (enzyme problem) or
- Stomach or bowel problems (eg, peptic ulcer, lesions) or
- Thrombasthenia (a platelet disorder) or
- Thrombocytopenia (low platelets in the blood) or
- Vitamin K deficiency or
- von Willebrand's disease (blood clotting disorder)—Should not be used in patients with these conditions.
- Chicken pox or
- Flu—Use with caution. May increase risk of having a condition called Reye's syndrome.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence.
Dosing
The dose of this medicine 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 of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (capsules):
- For tension headaches:
- Adults—1 or 2 capsules every 4 hours as needed. Do not take more than 6 capsules per day.
- Children—Use and dose must be determined by your doctor.
- For tension headaches:
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress while using this medicine to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine during the later part of your pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
Aspirin may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash, hives, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: bleeding under the skin, blurred vision, change in consciousness, confusion, confusion as to time, place, or person, continuing ringing or buzzing or other unexplained noise in the ears, difficult or labored breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position, extremely high fever or body temperature, hallucinations, irregular, fast, slow, or shallow breathing, fast, weak heartbeat, headache, hearing loss, holding false beliefs that cannot be changed by fact, loss of consciousness, muscle cramps, pale, clammy skin, pale or blue lips, fingernails, or skin, shakiness in the legs, arms, hands, feet, stomach pain, sweating, thirst, trembling or shaking of the hands or feet, trouble sleeping, unusual bleeding or bruising, unusual excitement, nervousness, or restlessness, unusual tiredness or weakness, or vomiting.
This medicine may cause bleeding in your stomach or intestines. This problem can happen without warning signs.
Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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 attention.
Check with your doctor immediately if any of the following side effects occur:
Less common
- Diarrhea
- indigestion
- loss of appetite
- nausea or vomiting
- passing gas
- stomach pain, fullness, or discomfort
Incidence not known
- Blistering, peeling, or loosening of the skin
- chest pain
- chills
- cough or hoarseness
- fever
- itching
- joint or muscle pain
- lower back or side pain
- painful or difficult urination
- red irritated eyes
- red skin lesions, often with a purple center
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Bleeding under the skin
- blurred vision
- change in consciousness
- confusion
- confusion as to time, place, or person
- continuing ringing or buzzing or other unexplained noise in the ears
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying position
- extremely high fever or body temperature
- hallucinations
- irregular, fast, slow, or shallow breathing
- fast, weak heartbeat
- headache
- hearing loss
- holding false beliefs that cannot be changed by fact
- loss of consciousness
- muscle cramps
- pale, clammy skin
- pale or blue lips, fingernails, or skin
- shakiness in the legs, arms, hands, or feet
- stomach pain
- sweating
- thirst
- trembling or shaking of the hands or feet
- trouble sleeping
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- vomiting
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Dizziness
- drowsiness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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