Acetaminophen and Butalbital Brand Names
Allzital | Axocet | Bucet | Bupap | Cephadyn | Dolgic | Marten | ORBIVAN CF | Phrenilin | Phrenilin Forte | Promacet | Repan CF | Sedapap | Tencon
What is Acetaminophen and Butalbital
Acetaminophen, a non-salicylate analgesic, and butalbital, a barbiturate, are used together in oral products to treat tension headaches in adult and pediatric patients 12 years of age and older, especially when antianxiety or relaxant effects are needed.
Treatment of multiple recurrent headaches with acetaminophen; butalbital has not been well studied and extended use of these products is not recommended.
No data from randomized, placebo-controlled trials to prove or refute the efficacy of acetaminophen; butalbital for the acute treatment of migraines are available.
According to published guidelines for the acute management of migraine, the use of butalbital-containing analgesics should be limited and carefully monitored due to concerns of overuse, medication-overuse headache, abuse, and withdrawal.
All acetaminophen-containing products carry a boxed warning in their prescribing information regarding the risk for hepatotoxicity, particularly with oral doses exceeding 4 grams/day.
Indications & Dosage
- headache
General dosing information:
- Maximum daily dosage limits for acetaminophen are based on all routes of administration (e.g., intravenous, oral, rectal) and all products containing acetaminophen, including both single-entity and combination products. Exceeding maximum daily dosage limits can result in hepatic injury, hepatic failure, and death. In an attempt to reduce the risk of hepatotoxicity, the FDA has recommended limiting the amount of acetaminophen in prescription combination products to 325 mg per dosage unit.
- Extended use is inadvisable due to the habit-forming and abusable nature of butalbital. The safety and efficacy of acetaminophen; butalbital for multiple, recurrent headaches is not established.
Side Effects
- abdominal pain
- acneiform rash
- acute generalized exanthematous pustulosis (AGEP)
- agitation
- agranulocytosis
- anaphylactoid reactions
- angioedema
- anorexia
- coma
- confusion
- constipation
- contact dermatitis
- diuresis
- dizziness
- drowsiness
- dyspepsia
- dysphagia
- dyspnea
- elevated hepatic enzymes
- emotional lability
- erythema
- erythema multiforme
- euphoria
- exfoliative dermatitis
- fatigue
- fever
- flatulence
- headache
- hemolysis
- hemolytic anemia
- hepatic encephalopathy
- hepatic failure
- hepatic necrosis
- hepatotoxicity
- hot flashes
- hyperhidrosis
- hypoprothrombinemia
- hypotension
- impaired cognition
- increased urinary frequency
- interstitial nephritis
- jaundice
- lethargy
- maculopapular rash
- malaise
- musculoskeletal pain
- nasal congestion
- nausea
- neutropenia
- otalgia
- pancytopenia
- paresthesias
- photosensitivity
- physiological dependence
- pruritus
- psychological dependence
- ptosis
- purpura
- rash
- renal failure (unspecified)
- renal papillary necrosis
- renal tubular necrosis
- respiratory depression
- seizures
- sinus tachycardia
- Stevens-Johnson syndrome
- syncope
- thrombocytopenia
- thrombocytosis
- tinnitus
- tolerance
- toxic epidermal necrolysis
- urticaria
- vertigo
- vomiting
- withdrawal
- xerostomia
Monitoring Parameters
- LFTs
- serum creatinine/BUN
Contraindications
- abrupt discontinuation
- acetaminophen hypersensitivity
- acute abdomen
- agranulocytosis
- alcoholism
- barbiturate hypersensitivity
- breast-feeding
- carbamazepine hypersensitivity
- children
- chronic obstructive pulmonary disease (COPD)
- CNS depression
- coadministration with other CNS depressants
- depression
- driving or operating machinery
- ethanol ingestion
- ethanol intoxication
- G6PD deficiency
- geriatric
- head trauma
- hepatic disease
- hepatitis
- hepatotoxicity
- hydantoin hypersensitivity
- hypovolemia
- infants
- malnutrition
- neonates
- porphyria
- potential for overdose or poisoning
- pregnancy
- pulmonary disease
- renal failure
- renal impairment
- respiratory depression
- sleep apnea
- substance abuse
- suicidal ideation
Interactions
- Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
- Abemaciclib
- Acetaminophen; Aspirin, ASA; Caffeine
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine
- Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine
- Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine
- Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine
- Acetaminophen; Codeine
- Acetaminophen; Dextromethorphan; Doxylamine
- Acetaminophen; Dichloralphenazone; Isometheptene
- Acetaminophen; Diphenhydramine
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Acetaminophen; Pentazocine
- Acetaminophen; Tramadol
- Acetazolamide
- Acrivastine; Pseudoephedrine
- Aldesleukin, IL-2
- Alfentanil
- Aliskiren; Amlodipine
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Aliskiren; Hydrochlorothiazide, HCTZ
- Alprazolam
- Altretamine
- Amiloride; Hydrochlorothiazide, HCTZ
- Aminosalicylate sodium, Aminosalicylic acid
- Amitriptyline; Chlordiazepoxide
- Amlodipine
- Amlodipine; Atorvastatin
- Amlodipine; Benazepril
- Amlodipine; Celecoxib
- Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Olmesartan
- Amlodipine; Telmisartan
- Amlodipine; Valsartan
- Amobarbital
- Amoxapine
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amprenavir
- Anagrelide
- Antacids
- Apomorphine
- Apraclonidine
- Apremilast
- Aprepitant, Fosaprepitant
- Aripiprazole
- Armodafinil
- Artemether; Lumefantrine
- Articaine; Epinephrine
- Asenapine
- Aspirin, ASA
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Aspirin, ASA; Caffeine; Dihydrocodeine
- Aspirin, ASA; Caffeine; Orphenadrine
- Aspirin, ASA; Carisoprodol
- Aspirin, ASA; Carisoprodol; Codeine
- Aspirin, ASA; Citric Acid; Sodium Bicarbonate
- Aspirin, ASA; Dipyridamole
- Aspirin, ASA; Omeprazole
- Aspirin, ASA; Oxycodone
- Aspirin, ASA; Pravastatin
- Atazanavir
- Atazanavir; Cobicistat
- Atenolol; Chlorthalidone
- Atorvastatin
- Atorvastatin; Ezetimibe
- Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
- Atropine; Difenoxin
- Atropine; Diphenoxylate
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Avanafil
- Avapritinib
- Avatrombopag
- Axitinib
- Azelastine
- Azelastine; Fluticasone
- Azilsartan; Chlorthalidone
- Barbiturates
- Bedaquiline
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Belladonna; Opium
- Benazepril; Hydrochlorothiazide, HCTZ
- Bendamustine
- Bendroflumethiazide; Nadolol
- Benzhydrocodone; Acetaminophen
- Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate
- Benztropine
- Bicalutamide
- Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
- Bismuth Subsalicylate
- Bismuth Subsalicylate; Metronidazole; Tetracycline
- Bisoprolol; Hydrochlorothiazide, HCTZ
- Boceprevir
- Bortezomib
- Brexpiprazole
- Brigatinib
- Brimonidine
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- Brimonidine; Timolol
- Brivaracetam
- Bromocriptine
- Brompheniramine
- Brompheniramine; Carbetapentane; Phenylephrine
- Brompheniramine; Dextromethorphan; Guaifenesin
- Brompheniramine; Guaifenesin; Hydrocodone
- Brompheniramine; Hydrocodone; Pseudoephedrine
- Brompheniramine; Pseudoephedrine
- Budesonide
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- Bupivacaine
- Bupivacaine Liposomal
- Bupivacaine; Lidocaine
- Buprenorphine
- Buprenorphine; Naloxone
- Bupropion
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- Buspirone
- Busulfan
- Butabarbital
- Butorphanol
- Caffeine
- Caffeine; Ergotamine
- Calcifediol
- Calcitriol
- Candesartan; Hydrochlorothiazide, HCTZ
- Cannabidiol
- Capmatinib
- Captopril; Hydrochlorothiazide, HCTZ
- Carbamazepine
- Carbetapentane; Chlorpheniramine
- Carbetapentane; Chlorpheniramine; Phenylephrine
- Carbetapentane; Diphenhydramine; Phenylephrine
- Carbetapentane; Guaifenesin
- Carbetapentane; Guaifenesin; Phenylephrine
- Carbetapentane; Phenylephrine
- Carbetapentane; Phenylephrine; Pyrilamine
- Carbetapentane; Pseudoephedrine
- Carbetapentane; Pyrilamine
- Carbidopa; Levodopa; Entacapone
- Carbinoxamine
- Carbinoxamine; Dextromethorphan; Pseudoephedrine
- Carbinoxamine; Hydrocodone; Phenylephrine
- Carbinoxamine; Hydrocodone; Pseudoephedrine
- Carbinoxamine; Phenylephrine
- Carbinoxamine; Pseudoephedrine
- Cardiac glycosides
- Cariprazine
- Cenobamate
- Cetirizine
- Cetirizine; Pseudoephedrine
- Cevimeline
- Charcoal
- Chlophedianol; Dexchlorpheniramine; Pseudoephedrine
- Chlorambucil
- Chloramphenicol
- Chlordiazepoxide
- Chlordiazepoxide; Clidinium
- Chloroprocaine
- Chlorothiazide
- Chlorpheniramine
- Chlorpheniramine; Codeine
- Chlorpheniramine; Dextromethorphan
- Chlorpheniramine; Dextromethorphan; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Phenylephrine
- Chlorpheniramine; Dihydrocodeine; Pseudoephedrine
- Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Hydrocodone
- Chlorpheniramine; Hydrocodone; Phenylephrine
- Chlorpheniramine; Hydrocodone; Pseudoephedrine
- Chlorpheniramine; Phenylephrine
- Chlorpheniramine; Pseudoephedrine
- Chlorthalidone
- Chlorthalidone; Clonidine
- Cholestyramine
- Choline Salicylate; Magnesium Salicylate
- Cinacalcet
- Citalopram
- Clemastine
- Clobazam
- Clonazepam
- Clorazepate
- Clozapine
- Cobimetinib
- Codeine
- Codeine; Guaifenesin
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- COMT inhibitors
- Conjugated Estrogens
- Conjugated Estrogens; Bazedoxifene
- Conjugated Estrogens; Medroxyprogesterone
- Cyclophosphamide
- Cyclosporine
- Cyproheptadine
- Dapsone
- Darifenacin
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Deflazacort
- Delavirdine
- Deutetrabenazine
- Dexamethasone
- Dexchlorpheniramine
- Dexchlorpheniramine; Dextromethorphan; Pseudoephedrine
- Dexmedetomidine
- Dextromethorphan; Diphenhydramine; Phenylephrine
- Dextromethorphan; Quinidine
- Diazepam
- Diclofenac
- Diclofenac; Misoprostol
- Dienogest; Estradiol valerate
- Diethylstilbestrol, DES
- Diflunisal
- Dihydrocodeine; Guaifenesin; Pseudoephedrine
- Diltiazem
- Dimenhydrinate
- Diphenhydramine
- Diphenhydramine; Hydrocodone; Phenylephrine
- Diphenhydramine; Ibuprofen
- Diphenhydramine; Naproxen
- Diphenhydramine; Phenylephrine
- Disopyramide
- Dolutegravir; Rilpivirine
- Donepezil
- Donepezil; Memantine
- Doravirine
- Doravirine; Lamivudine; Tenofovir disoproxil fumarate
- Doxercalciferol
- Doxorubicin
- Doxycycline
- Doxylamine
- Doxylamine; Pyridoxine
- Dronabinol
- Dronedarone
- Droperidol
- Drospirenone; Estradiol
- Drospirenone; Ethinyl Estradiol
- Drospirenone; Ethinyl Estradiol; Levomefolate
- Efavirenz
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Elagolix; Estradiol; Norethindrone acetate
- Elbasvir; Grazoprevir
- Eltrombopag
- Empagliflozin; Linagliptin
- Empagliflozin; Linagliptin; Metformin
- Emtricitabine; Rilpivirine; Tenofovir alafenamide
- Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
- Enalapril; Felodipine
- Enalapril; Hydrochlorothiazide, HCTZ
- Encorafenib
- Entacapone
- Entrectinib
- Eprosartan; Hydrochlorothiazide, HCTZ
- Erdafitinib
- Erlotinib
- Escitalopram
- Esketamine
- Eslicarbazepine
- Esomeprazole
- Esomeprazole; Naproxen
- Estazolam
- Esterified Estrogens
- Esterified Estrogens; Methyltestosterone
- Estradiol
- Estradiol Cypionate; Medroxyprogesterone
- Estradiol; Levonorgestrel
- Estradiol; Norethindrone
- Estradiol; Norgestimate
- Estradiol; Progesterone
- Estrogens
- Estropipate
- Eszopiclone
- Ethanol
- Ethinyl Estradiol
- Ethinyl Estradiol; Desogestrel
- Ethinyl Estradiol; Ethynodiol Diacetate
- Ethinyl Estradiol; Etonogestrel
- Ethinyl Estradiol; Levonorgestrel
- Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
- Ethinyl Estradiol; Levonorgestrel; Folic Acid; Levomefolate
- Ethinyl Estradiol; Norelgestromin
- Ethinyl Estradiol; Norethindrone
- Ethinyl Estradiol; Norethindrone Acetate
- Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
- Ethinyl Estradiol; Norethindrone; Ferrous fumarate
- Ethinyl Estradiol; Norgestimate
- Ethinyl Estradiol; Norgestrel
- Ethosuximide
- Exenatide
- Ezetimibe; Simvastatin
- Fedratinib
- Felodipine
- Fenoprofen
- Fentanyl
- Flibanserin
- Fluconazole
- Fluoxetine; Olanzapine
- Fluticasone
- Fluticasone; Salmeterol
- Fluticasone; Umeclidinium; Vilanterol
- Fluticasone; Vilanterol
- food
- Fosamprenavir
- Fosinopril; Hydrochlorothiazide, HCTZ
- Gabapentin
- Galantamine
- Gallium Ga 68 Dotatate
- General anesthetics
- Glasdegib
- Glimepiride
- Glimepiride; Pioglitazone
- Glimepiride; Rosiglitazone
- Green Tea
- Griseofulvin
- Guaifenesin; Hydrocodone
- Guaifenesin; Hydrocodone; Pseudoephedrine
- Guanfacine
- Haloperidol
- Hemin
- Homatropine; Hydrocodone
- Hydantoins
- Hydralazine; Hydrochlorothiazide, HCTZ
- Hydrochlorothiazide, HCTZ
- Hydrochlorothiazide, HCTZ; Irbesartan
- Hydrochlorothiazide, HCTZ; Lisinopril
- Hydrochlorothiazide, HCTZ; Losartan
- Hydrochlorothiazide, HCTZ; Methyldopa
- Hydrochlorothiazide, HCTZ; Metoprolol
- Hydrochlorothiazide, HCTZ; Moexipril
- Hydrochlorothiazide, HCTZ; Olmesartan
- Hydrochlorothiazide, HCTZ; Propranolol
- Hydrochlorothiazide, HCTZ; Quinapril
- Hydrochlorothiazide, HCTZ; Spironolactone
- Hydrochlorothiazide, HCTZ; Telmisartan
- Hydrochlorothiazide, HCTZ; Triamterene
- Hydrochlorothiazide, HCTZ; Valsartan
- Hydrocodone
- Hydrocodone; Ibuprofen
- Hydrocodone; Phenylephrine
- Hydrocodone; Potassium Guaiacolsulfonate
- Hydrocodone; Potassium Guaiacolsulfonate; Pseudoephedrine
- Hydrocodone; Pseudoephedrine
- Hydromorphone
- Hydroxyprogesterone
- Hydroxyzine
- Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate
- Ibuprofen; Oxycodone
- Ifosfamide
- Iloperidone
- Imatinib
- Indinavir
- Insulin Glargine; Lixisenatide
- Isavuconazonium
- Isocarboxazid
- Isoniazid, INH
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Isradipine
- Itraconazole
- Ivabradine
- Ixabepilone
- Ketoconazole
- Lamivudine, 3TC; Zidovudine, ZDV
- Lamotrigine
- Lansoprazole
- Lansoprazole; Naproxen
- Lanthanum Carbonate
- Lasmiditan
- Lefamulin
- Lemborexant
- Lesinurad
- Lesinurad; Allopurinol
- Leucovorin
- Levobupivacaine
- Levocetirizine
- Levoleucovorin
- Levorphanol
- Lidocaine
- Lidocaine; Prilocaine
- Linagliptin
- Linagliptin; Metformin
- Lithium
- Lixisenatide
- Lofexidine
- Lomitapide
- Lopinavir; Ritonavir
- Lorazepam
- Lorlatinib
- Lovastatin
- Lovastatin; Niacin
- Loxapine
- Lumateperone
- Lurasidone
- Magnesium Salicylate
- Magnesium Salts
- Mannitol
- Maprotiline
- Mebendazole
- Meclizine
- Mefloquine
- Melatonin
- Meperidine
- Meperidine; Promethazine
- Mephobarbital
- Mepivacaine
- Mepivacaine; Levonordefrin
- Meprobamate
- Mestranol; Norethindrone
- Metformin; Repaglinide
- Methadone
- Methazolamide
- Methocarbamol
- Methohexital
- Methscopolamine
- Methsuximide
- Methyclothiazide
- Methylprednisolone
- Metoclopramide
- Metolazone
- Metronidazole
- Metyrapone
- Metyrosine
- Mexiletine
- Midazolam
- Minocycline
- Mipomersen
- Mirtazapine
- Mitotane
- Modafinil
- Monoamine oxidase inhibitors
- Morphine
- Morphine; Naltrexone
- Nabilone
- Nalbuphine
- Nanoparticle Albumin-Bound Paclitaxel
- Nelfinavir
- Neratinib
- Nevirapine
- Niacin; Simvastatin
- Nicardipine
- Nifedipine
- Nimodipine
- Nintedanib
- Nisoldipine
- Olanzapine
- Olaparib
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole
- Omeprazole; Amoxicillin; Rifabutin
- Omeprazole; Sodium Bicarbonate
- Ondansetron
- Oxazepam
- Oxybutynin
- Oxycodone
- Oxymorphone
- Paclitaxel
- Paliperidone
- Papaverine
- Paroxetine
- Pemigatinib
- Penicillin G Benzathine; Penicillin G Procaine
- Penicillin G Procaine
- Pentazocine
- Pentazocine; Naloxone
- Pentobarbital
- Perampanel
- Perindopril; Amlodipine
- Phenelzine
- Phenobarbital
- Phenothiazines
- Phentermine; Topiramate
- Pimavanserin
- Pneumococcal Vaccine, Polyvalent
- Pomalidomide
- Posaconazole
- Pralidoxime
- Pramipexole
- Pramlintide
- Prednisolone
- Prednisone
- Pregabalin
- Prilocaine
- Prilocaine; Epinephrine
- Primidone
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- Progestins
- Quazepam
- Quetiapine
- Quinidine
- Quinine
- Rabeprazole
- Ramelteon
- Ranolazine
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- Red Yeast Rice
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- Rifampin
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- Riluzole
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- Ritonavir
- Roflumilast
- Romidepsin
- Ropinirole
- Ropivacaine
- Rotigotine
- Safinamide
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- Salsalate
- Saquinavir
- Scopolamine
- Secobarbital
- Segesterone Acetate; Ethinyl Estradiol
- Selegiline
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- Selumetinib
- Sertraline
- Sildenafil
- Simvastatin
- Simvastatin; Sitagliptin
- Siponimod
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- Skeletal Muscle Relaxants
- Sodium Bicarbonate
- Sodium Oxybate
- Spironolactone
- St. John’s Wort, Hypericum perforatum
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- Sunitinib
- Suvorexant
- Tacrolimus
- Tapentadol
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- Temazepam
- Terbinafine
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- Tetracaine
- Thalidomide
- Theophylline, Aminophylline
- Thiazide diuretics
- Thiopental
- Thiothixene
- Thyroid hormones
- Tipranavir
- Tizanidine
- tobacco
- Tolcapone
- Topiramate
- Tramadol
- Trandolapril; Verapamil
- Tranylcypromine
- Trazodone
- Tretinoin, ATRA
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- Triazolam
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- Trimethobenzamide
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- Triprolidine
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- Voxelotor
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- Zidovudine, ZDV
- Ziprasidone
- Zolmitriptan
- Zolpidem
- Zonisamide