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Data updated: May 26, 2026

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE (acetaminophen)

Pain Approved 1984-11-09

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is indicated for the treatment of Tension Headache.

Source: FDA Label • Teva
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
38
Indications
--
Phase 3 Trials
41
Years on Market

Details

Status
Prescription
First Approved
1984-11-09
Routes
ORAL
Dosage Forms
TABLET, CAPSULE, SOLUTION

Companies

Teva MIKART ALVOGEN TARO QUAGEN STRIDES PHARMA INGENUS PHARMS LLC Hikma AUROLIFE PHARMA LLC NESHER PHARMS LANNETT CO INC GRANULES STRIDES PHARMA INTL VINTAGE PHARMS MIRROR PHARMS LLC MALLINCKRODT WATSON LABS NUVO PHARMS INC Dr. Reddy's GILBERT LABS SPECGX LLC KEY THERAP ABLE LGM PHARMA GRAHAM DM ABHAI LLC SENORES PHARMS Sun Pharma GENUS
Active Ingredient: ACETAMINOPHEN , BUTALBITAL , CAFFEINE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Approval History

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Original
New Indication
New Form
Label Update
257 FDA actions from 1984 to 2025
Aug 2025 SUPPL
Label · Labeling
Mar 2024 ORIGINAL
Update
Feb 2024 ORIGINAL
Update

What BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Treats

1 indications

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Tension Headache
Source: FDA Label

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Boxed Warning

Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product....

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
ABLE
2003 1 indic.

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BUTALBITAL AND ACETAMINOPHEN
ACETAMINOPHEN
1 shared
GRANULES
Shared indications:
Tension Headache
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ACETAMINOPHEN
1 shared
QUAGEN
Shared indications:
Tension Headache
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
BUTALBITAL
1 shared
ABLE
Shared indications:
Tension Headache
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Clinical Trial Registry

251 trials
Trial Sponsor ID Phase Status Title
NCT04165096 results posted 3475-01C MK-3475-01C, KEYMAKER-U01C Ph 2 completed KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C)
NCT06009926 NCI-2023-06404 NCI-2023-06404, STUDY00003544 Ph 2 active not recruiting Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters
NCT07570173 1045-005 MK-1045-005, 2025-522267-15-00 Ph 2, Ph 3 recruiting A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
NCT05878015 23-000547 Ph 4 enrolling by invitation A Study of Intravenous Acetaminophen for Small Bowel Obstruction
NCT07567924 SIUT-ERC-2024/A-475 Ph 4 active not recruiting Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome
NCT04221477 REGENCY results posted CA41705 2019-004034-42, 2023-503628-22-00 Ph 3 active not recruiting A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
NCT06043323 2023-0087 NCI-2023-07173 Ph 2 recruiting A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma
NCT07571252 2603555595 Ph 4 not yet recruiting Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery
NCT06762600 HRS-4729-101 Ph 1 completed A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects
NCT07525791 NN9662-8158 U1111-1328-3457 Ph 1 recruiting A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight
NCT07508241 C6491010 MET097-25-106 Ph 1 recruiting A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity
NCT07525219 IRB00146434 Ph 3 not yet recruiting Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen
NCT03823534 28927 Ph 3 recruiting Post-Op Pain Control for Prophylactic Intramedullary Nailing.
NCT05722002 CARES HUM00215416 CER-2021C1-22398 Ph 4 recruiting Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial
NCT05285813 2021-1124 NCI-2022-02215 Ph 2 active not recruiting A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure
NCT03759028 IRB# 18-001158 Ph 4 recruiting Supracondylar Post-Operative Pain Study
NCT04629248 MAJESTY WA41937 2020-003233-38, 2023-506525-11-00 Ph 3 active not recruiting A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy
NCT06214468 23-067/2026659-2 Ph 1 completed Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity
NCT06187584 results posted STUDY00000286 Ph 4 completed Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management
NCT07502001 HDM1005-104 Ph 1 not yet recruiting Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin
NCT04268498 ADVANCE 20201316 2019-001645-41, 19-339 Ph 2 active not recruiting A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma
NCT03818932 results posted 123192 Ph 2, Ph 3 completed Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
NCT03258593 results posted 170157 17-C-0157 Ph 1 completed Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG)
NCT04459117 TREOCAPA C19-29 2019-004297-26 Ph 2, Ph 3 completed Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen
NCT05896228 Iber-KDd 20230227 Ph 2 recruiting Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma
NCT02858310 results posted 160154 16-C-0154 Ph 1, Ph 2 completed E7 TCR T Cells for Human Papillomavirus-Associated Cancers
NCT05597878 IRB00091354 WFBCCC 01122 Ph 2, Ph 3 suspended Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy
NCT06671002 CARES for Kids HUM00252793 BPS-2023C1-32147 Ph 4 recruiting Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial
NCT03974932 results posted HTX-011-306 Ph 3 completed Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
NCT03695367 results posted HTX-011-215 Ph 2 completed Phase 2 Herniorrhaphy Study for Opioid Elimination
NCT07429032 20230012 Ph 1 completed The Effect of AMG 133 on Gastric Emptying
NCT06356571 SubQSA LPS18183 U1111-1298-7348 Ph 2 recruiting A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT04224558 Pro00051458 Ph 1, Ph 2 recruiting Stem Cell Transplantation in Crohn's Disease
NCT06994442 OPTICOM 24-12028276 U01HD116260 Ph 3 recruiting Optimizing Pain Treatment in Children On Mechanical Ventilation
NCT03913559 INOMRD NCI-2019-01062 Ph 2 terminated Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia
NCT05488847 results posted 15592 Ph 4 active not recruiting Opioid-Free Pain Protocol After Shoulder Arthroplasty
NCT07101445 STUDY00008909 NCI-2025-03018, STUDY00008909 Ph 4 recruiting Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial
NCT05640674 results posted 52475 Ph 4 terminated Post-operative Pain Management in Children With Supracondylar Humerus Fractures
NCT04918147 results posted DAIT AIG01 UM1AI144298, NIAID CRMS ID#: 38708 Ph 2 terminated Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
NCT01391962 results posted 110200 11-C-0200 Ph 2 completed Sunitinib or Cediranib for Alveolar Soft Part Sarcoma
NCT04681105 20472 NCI-2020-08118, 20472 Ph 1 completed Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies
NCT06997016 Baylor IRB #025-220 Ph 4 enrolling by invitation Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
NCT02797522 results posted ARC5211001 Ph 1 terminated A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
NCT05211336 results posted 10000516 000516-C Ph 1 active not recruiting Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System
NCT03978767 PANDA 201901202 Ph 2 completed Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial
NCT05704049 IZALCO ACT17453 U1111-1280-5090, 2023-508870-27 Ph 2 active not recruiting A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma
NCT05603832 100-CIP02-P Ph 3 completed A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement
NCT04270409 EFC15992 U1111-1222-7068, 2023-507419-37 Ph 3 active not recruiting Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma
NCT03997851 results posted 20190133 Ph 1, Ph 2 completed Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects
NCT05035407 results posted 10000045 000045-C Ph 1 terminated T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Showing 50 of 251 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE FDA Label Details

Indications & Usage

FDA Label (PDF)

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is indicated for the treatment of Tension Headache.

⚠️ BOXED WARNING

Hepatotoxicity Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetamino...

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Data Sources

FDA Approval: ANDA088616 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.