Fortabs (Oral)

Butalbital, aspirin, and caffeine combination is used to relieve tension (or muscle contraction) headaches. It is not recommended to use this product for a long time or repeatedly.

Butalbital is part of a group of medicines called barbiturates. Barbiturates work on the central nervous system (CNS) to produce their effects.

Aspirin helps relieve pain and lower fever in patients. It is part of a group of medicines known as salicylates and works 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 enhance their effect. It has also been used for migraine headaches. Codeine is part of a group of medicines called narcotic analgesics (pain medicines). It works on the central nervous system (CNS) to relieve pain.

Using butalbital for a long time or in high doses may lead to habit-forming behavior, causing mental or physical dependence. Physical dependence may result in withdrawal side effects if you suddenly stop taking the medicine. In patients with headaches, the first sign of withdrawal may be new (rebound) headaches.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your progress while using this medicine to see if it is working properly and to decide if you should keep taking 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 may be pregnant while using this medicine, tell your doctor immediately.

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 using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not take more than your prescribed dose. Call your doctor for instructions.

This medicine will increase the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants include 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 using this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help immediately. Signs of an overdose include: bleeding under the skin, blurred vision, change in consciousness, confusion, confusion about time, place, or person, continuous 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 signs 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.

In deciding to use a medication, the risks of using the medicine must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this medicine, the following should be considered:

Allergies

Tell your clinician if you have ever had any unusual or allergic reaction to this medicine or any other medications. Additionally 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 guidance 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 issues, which may require caution and an adjustment in the dose for patients receiving this drug.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to using 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 using this drug, it is especially important that your healthcare professional know if you are using any of the drugs 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 drugs is not advised. Your clinician may decide not to treat you with this medicine or change some of the other medicines you take.

• Abrocitinib
• Defibrotide
• Dichlorphenamide
• Influenza Virus Vaccine, Live
• Ketorolac
• Riociguat
• Viloxazine

Using this drug with any of the following medicines is normally not recommended, but may be required in some cases. If both medicines are prescribed together, your clinician may change the dose or how often you use one or both of the medications.

• 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
• Capmatinib
• Capreomycin
• Captopril
• Carisoprodol
• 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 chance of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your physician may change the dose or how often you use one or both of the medications.

• 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 additionally 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 clinician may change the dose or how frequently you use this drug, 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 chance of certain adverse effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how frequently you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

The presence of other medical problems may affect the use of this medicine. Make sure you inform your clinician if you have any other medical issues, especially:

• Addison's disease (an adrenal issue) or
• Alcohol or drug abuse or dependence, or history of or
• Brain tumor, history of, or
• Breathing issues (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 severe 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 issues (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 raise risk of having a condition called Reye's syndrome.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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.

In the U.S.

• Fiorinal
• Fortabs
• Laniroif

Available Dosage Forms:

• Capsule
• Tablet

Therapeutic Class: Butalbital/Salicylate, Aspirin Combination

Pharmacologic Class: Barbiturate

Chemical Class: Salicylate, Aspirin

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.