Drug information of Butalbital and Acetaminophen

Butalbital and Acetaminophen

Drug group:

Acetaminophen is a pain reliever and fever reducer.

Butalbital is a barbiturate. It relaxes muscle contractions involved in a tension headache.

Acetaminophen and butalbital is a combination medicine used to treat tension headaches. acetaminophen and butalbital is not for treating headaches that come and go.

Mechanism of effect

Butalbital: Short- to intermediate-acting barbiturate; depresses the sensory cortex, decreases motor activity, alters cerebellar function, and produces drowsiness, sedation, hypnosis, and dose-dependent respiratory depression.

Acetaminophen: Although not fully elucidated, the analgesic effects are believed to be due to activation of descending serotonergic inhibitory pathways in the CNS. Interactions with other nociceptive systems may be involved as well (Smith 2009). Antipyresis is produced from inhibition of the hypothalamic heat-regulating center.


Butalbital: Well absorbed
Half life
Butalbital: ~35 hours
Butalbital: Urine (59% to 88% as unchanged drug or metabolites)

Drug indications

Tension or muscle contraction headache: Relief of the symptomatic complex of tension or muscle contraction headache


Usual Adult Dose for Headache
Butalbital 50 mg/acetaminophen 300 or 325 mg
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day
Butalbital 25 mg/acetaminophen 325 mg
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day
Usual Pediatric Dose for Headache
12 years or older
Butalbital 50 mg/acetaminophen 300 or 325 mg
1 or 2 tablets orally every 4 hours as needed not to exceed 6 tablets per day
Butalbital 25 mg/acetaminophen 325 mg
2 tablets orally every 4 hours as needed not to exceed 12 tablets per day

Drug contraindications

Hypersensitivity to butalbital, acetaminophen, or any component of the formulation; porphyria

Side effects

Frequency not defined.
Cardiovascular: Tachycardia
Central nervous system: Agitation, confusion, depression, dizziness, drowsiness, euphoria, excitement, headache, increased energy, intoxicated feeling, lethargy, numbness, paresthesia, sedation, seizure, shakiness
Dermatologic: Hyperhidrosis, pruritus
Endocrine & metabolic: Hot flash
Gastrointestinal: Abdominal pain, constipation, dysphagia, flatulence, heartburn, nausea, vomiting, xerostomia
Genitourinary: Diuresis
Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Leg pain, muscle fatigue
Otic: Otalgia, tinnitus
Respiratory: Dyspnea, nasal congestion
Miscellaneous: Fever, heavy eyelids
, postmarketing, and/or case reports: Erythema multiforme, toxic epidermal necrolysis

Alcohol (Ethyl), Alizapride, Azelastine (Nasal), Barbiturates, Beta-Blockers, Blonanserin,
Blood Pressure Lowering Agents, Brexanolone, Brimonidine (Topical), Bromopride, Bromperidol, Buprenorphine, Busulfan, Calcium Channel Blockers, Cannabidiol, Cannabis,
CarBAMazepine, Chlormethiazole, Chlorphenesin Carbamate, CNS Depressants, CycloSPORINE (Systemic), Dapsone (Topical), Dasatinib, Dimethindene (Topical), Doxycycline, Doxylamine,
Dronabinol, Droperidol, Esketamine, Estrogen Derivatives (Contraceptive), Felbamate, Flucloxacillin, Flunitrazepam, Fosphenytoin-Phenytoin, Griseofulvin, Hemin, HydrOXYzine,
Imatinib, Isoniazid, Kava Kava, LamoTRIgine, Lemborexant, Lisuride, Local Anesthetics, Lofexidine, Lorlatinib, Magnesium Sulfate, Methotrimeprazine, Methoxyflurane, Mianserin,
Metoclopramide, MetyraPONE, MetyroSINE, Minocycline (Systemic), Mipomersen, Nabilone,
Multivitamins/Minerals (with ADEK, Folate, Iron), Nitric Oxide, Opioid Agonists, Orphenadrine,
Oxomemazine, OxyCODONE, Paraldehyde, Perampanel, Phenylephrine (Systemic), Piribedil,
Pramipexole, Prilocaine, Primidone, Probenecid, Progestins (Contraceptive), Propacetamol,
Pyridoxine, Rifamycin Derivatives, ROPINIRole, Rotigotine, Rufinamide, Sodium Nitrite, Sodium Oxybate, Somatostatin Acetate, SORAfenib, Suvorexant, Teniposide, Tetrahydrocannabinol,
Tetrahydrocannabinol and Cannabidiol, Thalidomide, Theophylline Derivatives, Tricyclic Antidepressants, Trimeprazine, Ulipristal, Valproate Products, Vitamin K Antagonists (eg, warfarin), Voriconazole, Zolpidem


This medicine has acetaminophen in it. Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen

Avoid alcohol or other drugs and natural products that slow your actions

Be careful if you have G6PD deficiency. Anemia may happen

If you are 65 or older, use butalbital and acetaminophen with care. You could have more side effects

Due to high rate of physical dependence, the extended use of this drug is not recommended

The safety and efficacy of treating multiple recurrent headaches with this product is not known

Safety and efficacy have not been established in patients younger than 12 years

Points of recommendation

؟What do I need to tell my doctor BEFORE I take Butalbital and Acetaminophen
If you have an allergy to butalbital, acetaminophen, or any other part of butalbital and acetaminophen
If you have porphyria
If you are breast-feeding or plan to breast-feed

Avoid driving and doing other tasks or actions that call for alertness while you take butalbital and acetaminophen

This medicine may be habit-forming with long-term use

Do not take butalbital and acetaminophen for longer than you were told by your doctor

If you have been taking butalbital and acetaminophen for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if butalbital and acetaminophen stops working well. Do not take more than ordered

If you have been taking butalbital and acetaminophen on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking butalbital and acetaminophen all of a sudden without calling your doctor. Tell your doctor if you have any bad effects

Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems

This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take butalbital and acetaminophen

Follow the directions exactly. Do not take more acetaminophen in a day than directed. If you do not know how much acetaminophen you can take in a day, ask your doctor or pharmacist. Some people may take up to 4,000 mg (milligrams) in a day if told to do so by the doctor. Some people (like people with liver problems and children) should take less acetaminophen. Call your doctor right away if you have taken too much acetaminophen in a day, even if you feel well

Take with or without food. Take with food if it causes an upset stomach

Store at room temperature
Protect from light
Store in a dry place. Do not store in a bathroom

Pregnancy level


Pregnancy category: C

Breast feeding warning

Lactation: excreted in breast milk; caution advised

Drug forms

Allzital, Bupap, Marten-Tab

Ask a Pharmacist

User's questions
    No comments yet.