Description
Butalbital and acetaminophen combination is used to relieve symptoms of tension (or muscle contraction) headaches.
Butalbital belongs to the group of medicines called barbiturates. They act in the central nervous system (CNS) to produce their effects.
Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including serious liver damage. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Capsule
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 and acetaminophen combination in children younger than 12 years of age. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of butalbital and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart 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 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.
- Acepromazine
- Alfentanil
- Alprazolam
- Amobarbital
- Anileridine
- Anisindione
- Aprobarbital
- Aripiprazole
- Aripiprazole Lauroxil
- Asenapine
- Baclofen
- Benperidol
- Bentazepam
- Benzhydrocodone
- Bromazepam
- Buprenorphine
- Buspirone
- Butabarbital
- Butorphanol
- Calcium Oxybate
- Cannabidiol
- Cannabis
- Carbamazepine
- Carbinoxamine
- Carisoprodol
- Carphenazine
- Cetirizine
- Chloral Hydrate
- Chlordiazepoxide
- Chlorpromazine
- Chlorzoxazone
- Clobazam
- Clonazepam
- Clorazepate
- Cloxazolam
- Clozapine
- Codeine
- Cyclobenzaprine
- Dantrolene
- Daridorexant
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.
- Acenocoumarol
- Fosphenytoin
- Lixisenatide
- Ospemifene
- Phenytoin
- Prednisone
- St John's Wort
- Warfarin
- Zidovudine
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.
- Cabbage
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:
- Alcohol or drug abuse or dependence, or history of—Use with caution. May increase risk for more serious side effects.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Porphyria (enzyme problem)—Should not be used in patients with this condition.
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. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.
Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours), as this may increase the risk for serious liver problems.
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 tension headaches::
- For oral dosage form (capsules):
- Adults and children 12 years of age and older—1 or 2 capsules every 4 hours. However, the dose is usually not more than 6 capsules per day. Do not exceed 4 grams (4000 milligrams) of acetaminophen (Tylenol®) per day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults and children 12 years of age and older—1 or 2 tablets every 4 hours as needed. However, the dose is usually not more than 6 tablets per day. Do not exceed 4 grams (4000 milligrams) of acetaminophen (Tylenol®) per day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (capsules):
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 you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, cough, dizziness, fast heartbeat, hives, rash, itching, puffiness or swelling of the eyelids, or around the eyes, face, lips, or tongue, trouble breathing or swallowing, or unusual tiredness or weakness while you are using this medicine.
This medicine may make you dizzy, drowsy, confused, or disoriented. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Do not suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent a possible worsening of your condition and reduce the possibility of withdrawal symptoms such as confusion as to time, place, or person, hallucinations, holding false beliefs that cannot be changed by fact, seizures, or unusual excitement, nervousness, or restlessness.
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.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
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. Also, there may be a greater risk of liver damage if you drink 3 or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and 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: black, tarry stools, bloody or cloudy urine, blurred vision, change in consciousness, chills, confusion, dark urine, difficult or painful urination, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fever, headache, irregular, fast or slow, or shallow breathing, itching, light-colored stools, loss of appetite, loss of consciousness, nausea, pale or blue lips, fingernails, or skin, sleepiness, stomach pain, sudden decrease in amount of urine, sweating, trouble breathing, unpleasant breath odor, unusual tiredness or weakness, vomiting of blood, or yellow eyes or skin.
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:
More common
- Dizziness
- lightheadedness
- sleepiness
- trouble breathing
Less common
- Anxiety
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- chest tightness
- chills
- cough or hoarseness
- diarrhea
- difficulty swallowing
- discouragement
- dry mouth
- excitement
- fainting
- false or unusual sense of well-being
- fast, pounding, or irregular heartbeat or pulse
- feeling sad or empty
- headache
- heavy eyelids
- high energy
- hives, itching, skin rash
- hot spells
- hyperventilation
- irregular heartbeats
- irritability
- joint or muscle pain
- lack of appetite
- loss of interest or pleasure
- lower back or side pain
- mental confusion
- nervousness
- painful or difficult urination
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- red irritated eyes
- red skin lesions, often with a purple center
- restlessness
- seizures
- shaky feeling
- sluggishness
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- trouble concentrating
- trouble sleeping
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- Dark urine
- loss of appetite
- nausea or vomiting
- stomach pain, severe
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Black, tarry stools
- bloody or cloudy urine
- blurred vision
- change in consciousness
- chills
- confusion
- dark urine
- difficult or painful urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fever
- headache
- irregular, fast or slow, or shallow breathing
- itching
- light-colored stools
- loss of appetite
- loss of consciousness
- nausea
- pale or blue lips, fingernails, or skin
- sleepiness
- stomach pain
- sudden decrease in amount of urine
- sweating
- trouble breathing
- unpleasant breath odor
- unusual tiredness or weakness
- vomiting of blood
- yellow eyes or skin
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:
Less common
- Bloated
- constipation
- continuing ringing or buzzing or other unexplained noise in the ears
- dry mouth
- earache
- excess air or gas in the stomach or intestines
- full feeling
- hearing loss
- heartburn
- increased sweating
- indigestion
- leg pain
- passing gas
- stuffy nose
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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