Butalbital, aspirin, and caffeine

Generic name: Butalbital, Aspirin, And Caffeine
Drug class: Analgesic combinations

Usage of Butalbital, aspirin, and caffeine

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.

Butalbital, aspirin, and caffeine 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.

Before taking Butalbital, aspirin, and caffeine

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.

Breast Feeding

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.

Interactions with Medicines

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

Acetazolamide

Alclometasone

Aldosterone

Alfentanil

Alipogene Tiparvovec

Alprazolam

Alteplase, Recombinant

Amcinonide

Amikacin

Amiloride

Amineptine

Amitriptyline

Amitriptylinoxide

Amobarbital

Amoxapine

Amphotericin B

Amtolmetin Guacil

Anagrelide

Anisindione

Apixaban

Aprobarbital

Ardeparin

Argatroban

Bacitracin

Barbital

Beclomethasone

Bemetizide

Bemiparin

Benazepril

Bendroflumethiazide

Benzthiazide

Betamethasone

Betrixaban

Bivalirudin

Brinzolamide

Bromfenac

Budesonide

Bufexamac

Bumetanide

Butabarbital

Calcium Oxybate

Caplacizumab-yhdp

Celecoxib

Certoparin

Chloral Hydrate

Chlordiazepoxide

Chlorothiazide

Chlorpropamide

Chlorthalidone

Chlorzoxazone

Choline Salicylate

Ciclesonide

Cilostazol

Cisplatin

Citalopram

Clarithromycin

Clobetasol

Clobetasone

Clocortolone

Clomipramine

Clonazepam

Clonixin

Clopamide

Clopidogrel

Clorazepate

Cortisone

Curcumin

Cyclopenthiazide

Cyclosporine

Cyclothiazide

Dabigatran Etexilate

Dalteparin

Danaparoid

Dantrolene

Darunavir

Deflazacort

Desipramine

Desirudin

Desmopressin

Desonide

Desoximetasone

Desvenlafaxine

Dexamethasone

Dexibuprofen

Dexketoprofen

Diazepam

Diazoxide

Dibenzepin

Diclofenac

Dicumarol

Diflorasone

Diflucortolone

Diflunisal

Difluprednate

Digoxin

Dipyrone

Dorzolamide

Dothiepin

Doxepin

Doxorubicin

Doxorubicin Hydrochloride Liposome

Drospirenone

Droxicam

Duloxetine

Edoxaban

Emtricitabine

Enalapril

Enalaprilat

Enoxaparin

Eplerenone

Eptifibatide

Escitalopram

Esketamine

Estazolam

Eterobarb

Ethacrynic Acid

Ethchlorvynol

Ethinyl Estradiol

Etodolac

Etofenamate

Etonogestrel

Etoricoxib

Etozolin

Felbinac

Fenoprofen

Fepradinol

Feprazone

Feverfew

Floctafenine

Flucloronide

Fludrocortisone

Flufenamic Acid

Flumethasone

Flunisolide

Flunitrazepam

Fluocinolone

Fluocinonide

Fluocortin

Fluocortolone

Fluorometholone

Fluoxetine

Flurandrenolide

Flurazepam

Flurbiprofen

Fluticasone

Fluvoxamine

Fondaparinux

Foscarnet

Fosinopril

Fosphenytoin

Furosemide

Gentamicin

Ginkgo

Givosiran

Glimepiride

Glipizide

Glyburide

Gossypol

Halazepam

Halcinonide

Halobetasol

Heparin

Heptabarbital

Hexobarbital

Hydrochlorothiazide

Hydrocortisone

Hydroflumethiazide

Ibrutinib

Ibuprofen

Imipramine

Indapamide

Indomethacin

Inotersen

Iobenguane I 131

Isocarboxazid

Kanamycin

Ketazolam

Ketoprofen

Lepirudin

Levomilnacipran

Linezolid

Lisinopril

Lithium

Lofepramine

Lorazepam

Lormetazepam

Lornoxicam

Loteprednol

Loxoprofen

Lumiracoxib

Macimorelin

Magnesium Oxybate

Meclofenamate

Medazepam

Medrysone

Mefenamic Acid

Melitracen

Meloxicam

Melphalan

Mephenesin

Mephobarbital

Meprobamate

Metaxalone

Metformin

Methazolamide

Methocarbamol

Methohexital

Methotrexate

Methyclothiazide

Methylene Blue

Methylprednisolone

Metolazone

Midazolam

Milnacipran

Moexipril

Mometasone

Morniflumate

Nabumetone

Nadroparin

Naproxen

Nateglinide

Nefazodone

Neomycin

Nepafenac

Netilmicin

Nicorandil

Nifedipine

Niflumic Acid

Nimesulide

Nimesulide Beta Cyclodextrin

Nitrazepam

Norethindrone

Norgestimate

Norgestrel

Nortriptyline

Opipramol

Oxaprozin

Oxazepam

Oxyphenbutazone

Ozanimod

Paramethasone

Parecoxib

Parnaparin

Paromomycin

Paroxetine

Peginterferon Alfa-2b

Pemetrexed

Pentobarbital

Pentosan Polysulfate Sodium

Pentoxifylline

Perindopril

Phenelzine

Phenindione

Phenobarbital

Phenprocoumon

Phenylbutazone

Phenytoin

Piketoprofen

Piperaquine

Piracetam

Piretanide

Piroxicam

Pixantrone

Plazomicin

Polythiazide

Potassium Citrate

Potassium Oxybate

Pranoprofen

Prasugrel

Prazepam

Prednicarbate

Prednisolone

Prednisone

Primidone

Procarbazine

Proglumetacin

Propyphenazone

Proquazone

Protein C

Protriptyline

Quazepam

Quinapril

Quinethazone

Ramipril

Rasagiline

Repaglinide

Reteplase, Recombinant

Reviparin

Rimexolone

Ritlecitinib

Rivaroxaban

Rofecoxib

Safinamide

Salicylic Acid

Salsalate

Secobarbital

Selegiline

Selumetinib

Sertraline

Sodium Oxybate

Sodium Salicylate

Spectinomycin

Spirapril

Spironolactone

Streptomycin

Sulindac

Sulodexide

Tacrolimus

Temazepam

Tenofovir Alafenamide

Tenofovir Disoproxil Fumarate

Tenoxicam

Thiopental

Tianeptine

Tiaprofenic Acid

Ticagrelor

Ticlopidine

Tinzaparin

Tirofiban

Tobramycin

Tocilizumab

Tolazamide

Tolbutamide

Tolfenamic Acid

Tolmetin

Torsemide

Trandolapril

Tranylcypromine

Trazodone

Treprostinil

Triamcinolone

Triamterene

Triazolam

Trichlormethiazide

Trimipramine

Turmeric

Ulipristal

Valdecoxib

Valproic Acid

Vancomycin

Varicella Virus Vaccine, Live

Venlafaxine

Vilazodone

Vortioxetine

Warfarin

Xipamide

Zotepine

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

Interactions with Food/Tobacco/Alcohol

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

Relate drugs

How to use Butalbital, aspirin, and caffeine

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.

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.

Warnings

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.

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