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Acetaminophen

Generic Name
Acetaminophen
Brand Names
Acephen, Acetadryl, Allzital, Apadaz, Arthriten Inflammatory Pain, Bupap, Butapap, Cetafen, Children's Silapap, Coricidin Hbp Cold & Flu, Darvocet-N, Dayquil Sinex, Diphen, Dolofin, Dologen, Dologesic Reformulated Jun 2016, Duralgina, Dvorah, Endocet, Esgic, Exaprin, Excedrin, Excedrin PM Triple Action, Excedrin Tension Headache, Feverall, Fioricet, Fioricet With Codeine, Goody's Back & Body Pain Relief, Goody's Body Pain, Goody's Extra Strength, Goody's Headache Relief Shot, Goody's PM, Hycet, Legatrin PM, Little Fevers, Lorcet, Lortab, Mapap, Mersyndol, Midol Complete, Midol Cramps & Bodyaches, Nalocet, Norco, Orbivan, Pamprin Max Formula, Pamprin Multi-symptom, Panadol, Pediacare Children's Fever Reducer Pain Reliever, Percocet, Percogesic Reformulated Jan 2011, Pharbetol, Premsyn Pms, Prolate, Rivacocet, Robaxacet, Robaxacet-8, Roxicet, Sudafed PE Sinus Headache, Tactinal, Tencon, Trezix, Triatec, Triatec-30, Triatec-8, Tylenol, Tylenol PM, Tylenol With Codeine, Ultracet, Vanatol, Vanatol S, Vanquish, Xodol, Xolox, Zamicet, Zflex, Zydone
Drug Type
Small Molecule
Chemical Formula
C8H9NO2
CAS Number
103-90-2
Unique Ingredient Identifier
362O9ITL9D

Overview

Acetaminophen (paracetamol), also commonly known as Tylenol, is the most commonly taken analgesic worldwide and is recommended as first-line therapy in pain conditions by the World Health Organization (WHO). It is also used for its antipyretic effects, helping to reduce fever. This drug was initially approved by the U.S. FDA in 1951 and is available in a variety of forms including syrup form, regular tablets, effervescent tablets, injection, suppository, and other forms. Acetaminophen is often found combined with other drugs in more than 600 over the counter (OTC) allergy medications, cold medications, sleep medications, pain relievers, and other products. Confusion about dosing of this drug may be caused by the availability of different formulas, strengths, and dosage instructions for children of different ages. Due to the possibility of fatal overdose and liver failure associated with the incorrect use of acetaminophen, it is important to follow current and available national and manufacturer dosing guidelines while this drug is taken or prescribed.

Indication

In general, acetaminophen is used for the treatment of mild to moderate pain and reduction of fever. It is available over the counter in various forms, the most common being oral forms. Acetaminophen injection is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. Because of its low risk of causing allergic reactions, this drug can be administered in patients who are intolerant to salicylates and those with allergic tendencies, including bronchial asthmatics. Specific dosing guidelines should be followed when administering acetaminophen to children.

Associated Conditions

  • Acute Gouty Arthritis
  • Acute Musculoskeletal Pain
  • Allergic Reaction
  • Allergy to Tree Pollen
  • Ankylosing Spondylitis (AS)
  • Chills
  • Cold
  • Common Cold
  • Cough
  • Cough caused by Common Cold
  • Coughing caused by Flu caused by Influenza
  • Dyskinesia of the Biliary Tract
  • Dyskinesia of the Urinary Tract
  • Febrile Convulsions
  • Febrile Illness Acute
  • Fever
  • Fibromyalgia
  • Flu caused by Influenza
  • Headache
  • Joint dislocations
  • Menstrual Distress (Dysmenorrhea)
  • Mild pain
  • Muscle Inflammation
  • Muscle Injuries
  • Muscle Spasms
  • Musculoskeletal Pain
  • Myalgia
  • Nasal Congestion
  • Neuropathic Pain
  • Osteoarthritis (OA)
  • Pain
  • Postoperative pain
  • Premenstrual cramps
  • Rheumatoid Arthritis
  • Rhinopharyngitis
  • Rhinorrhoea
  • Severe Pain
  • Sinusitis
  • Spasms
  • Spastic Pain of the Gastrointestinal Tract
  • Sprains
  • Symptoms Cold
  • Tension Headache
  • Toothache
  • Upper Respiratory Tract Infection
  • Whiplash Syndrome
  • Acute Torticollis
  • Articular inflammation
  • Cold or flu syndrome
  • Mild to moderate pain
  • Minor aches and pains
  • Minor pain
  • Moderate Pain
  • Moderate to severe pain

Research Report

Published: May 29, 2025

Acetaminophen: A Comprehensive Pharmacological and Clinical Review

1. Introduction to Acetaminophen

1.1. Overview and Therapeutic Class

Acetaminophen, known internationally as paracetamol, is a globally recognized non-opioid analgesic and antipyretic agent.[1] It is widely available both over-the-counter (OTC) and as a prescription medication. The World Health Organization (WHO) recommends acetaminophen as a first-line therapeutic option for the management of mild to moderate pain.[1] Its primary clinical applications are the relief of pain and the reduction of fever, establishing it as a fundamental medication in symptomatic treatment for a diverse range of conditions.[3]

1.2. Chemical Properties and Identifiers

Acetaminophen is classified pharmacologically as a Small Molecule [User Query]. For precise identification in scientific and regulatory contexts, it is assigned the Chemical Abstracts Service (CAS) Number 103-90-2 and the DrugBank Accession Number DB00316 [User Query]. These identifiers are essential for accurate referencing in research, clinical databases, and chemical inventories.

1.3. Significance in Clinical Practice

Acetaminophen is one of the most frequently used medications for pain and fever relief in both the United States and Europe.[1] Its pervasive use is highlighted by its presence as an active ingredient in over 600 different OTC and prescription medicinal products, including standalone analgesics, fever reducers, sleep aids, and various combination formulations for cough, cold, and allergy symptoms.[5] The enduring clinical significance of acetaminophen is founded on its well-established efficacy for common ailments and a generally favorable safety profile when administered according to recommended dosing guidelines. This has solidified its position as an indispensable component of household medicine cabinets worldwide.[2]

Continue reading the full research report

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2023/04/28
Phase 4
Terminated
2023/04/14
N/A
Completed
2023/03/13
Phase 2
Completed
2023/03/09
Phase 3
Completed
Johnson & Johnson Consumer Inc. (J&JCI)
2023/02/10
Phase 4
Recruiting
2023/02/10
Phase 2
Recruiting
2023/01/30
Phase 2
Recruiting
2023/01/18
Not Applicable
Completed
Ho Chi Minh City Hospital of Dermato-Venereology
2023/01/10
Phase 4
Recruiting
2022/12/12
Phase 1
Not yet recruiting

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Unit Dose Services
50436-4856
ORAL
325 mg in 1 1
8/12/2011
Bryant Ranch Prepack
71335-1444
ORAL
325 mg in 1 1
3/10/2021
PAI Holdings, LLC
0121-0772
ORAL
325 mg in 15 mL
7/6/2023
Bryant Ranch Prepack
72162-2510
ORAL
325 mg in 1 1
5/23/2025
Quality Care Products, LLC
49999-060
ORAL
300 mg in 1 1
4/21/2022
Preferred Pharmaceuticals Inc.
68788-8585
ORAL
500 mg in 1 1
5/7/2025
Bryant Ranch Prepack
72162-2271
ORAL
325 mg in 1 1
3/18/2024
RedPharm Drug Inc.
67296-0544
ORAL
300 mg in 1 1
5/23/2011
McKesson Medical-Surgical, Inc.
68599-4679
ORAL
325 mg in 1 1
9/9/2025
SpecGx LLC
0406-0123
ORAL
325 mg in 1 1
1/3/2024

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
RICOFLU COLDS AND FLU RELIEF TABLETS
SIN09235P
TABLET
400 mg
3/5/1997
HORGESIC TABLET 35MG/450MG
SIN16415P
TABLET
450 mg
1/7/2022
UNIFLU COLDS & FLU TABLETS
SIN07102P
TABLET
400 mg
7/7/1992
NORPHEN TABLET
ATLANTIC LABORATORIES CORPN LTD
SIN12142P
TABLET
450 mg
12/5/2002
ULTRADOL F.C. TABLETS 37.5MG/325MG
SIN16498P
TABLET, FILM COATED
325mg
5/19/2022
CAMGESIC TABLET
SIN09867P
TABLET
450 mg
7/2/1998
Panadol Cold Relief PE Caplet
Aspen Pharma Pty Ltd.
SIN13878P
TABLET
500 mg
10/27/2010
NORGESIC TABLET
SIN05552P
TABLET
450 mg
3/20/1991
PANADOL MENSTRUAL CAPLET
STERLING DRUG (M) SDN BHD
SIN11051P
TABLET, FILM COATED
500 mg
7/28/1999
Panadol Sinus MAX Caplet 500mg/5mg
Aspen Pharma Pty Ltd.
SIN13877P
TABLET
500 mg
10/27/2010

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
PDP-ACETAMINOPHEN SOLUTION 80MG/ML
pendopharm division of pharmascience inc
00887587
Drops - Oral
80 MG / ML
12/31/1990
PAT-TRAMADOL/ACET
02389274
Tablet - Oral
325 MG
8/14/2012
MEDICAMENT POUR LES SINUS, EXTRA-FORT
laboratoire riva inc.
02240563
Tablet - Oral
500 MG
4/19/2000
PEDIAPHEN
euro-pharm international canada inc
02241478
Tablet - Oral
80 MG
12/23/1999
MEDICAMENT POUR LES SINUS, REGULIER
laboratoire riva inc.
02240562
Tablet - Oral
325 MG
4/19/2000
MIDOL MULTI-SYMPTOM CAPLETS EXTRA STRENGTH
bayer inc consumer care
02150484
Tablet - Oral
500 MG / TAB
12/31/1995
MIDOL ONE
Bayer Inc
02273438
Tablet - Oral
325 MG
N/A
MUSCLE AND BACK PAIN RELIEF
teva canada limited
02237995
Tablet - Oral
325 MG
7/30/1999
NITETIME COLD MEDICINE LIQ
01900501
Liquid - Oral
650 MG / 30 ML
12/31/1992
HOT LEMON NIGHT TIME TOTAL EXTRA STRENGTH
cellchem pharmaceuticals inc.
02338416
Powder For Solution - Oral
650 MG / SACHET
N/A

CIMA AEMPS Drug Approvals

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Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TRAMADOL/PARACETAMOL ARISTO 75 MG/650 MG COMPRIMIDOS EFERVESCENTES
Aristo Pharma Iberia S.L.
86603
COMPRIMIDO EFERVESCENTE
Medicamento Sujeto A Prescripción Médica
Not Commercialized
TRAMADOL/PARACETAMOL APOTEX 37,5 MG/325 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Apotex Europe B.V.
77374
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Not Commercialized
TRACIMOL 37,5 MG / 325 MG COMPRIMIDOS EFG
Acino Ag
77342
COMPRIMIDO
Medicamento Sujeto A Prescripción Médica
Not Commercialized
PARACETAMOL SERRACLINICS 10 mg/ml SOLUCION PARA PERFUSION
Laboratorios Serra Pamies S.A.
68475
SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
NORMOGRIP ANTITUSIVO GRANULADO PARA SOLUCION ORAL
Laboratorios Normon S.A.
88698
GRANULADO PARA SOLUCIÓN ORAL
Sin Receta
Commercialized
COD-EFFERALGAN 500 mg/ 30 mg comprimidos efervescentes
Upsa S.A.S.
60748
COMPRIMIDO EFERVESCENTE
Medicamento Sujeto A Prescripción Médica
Commercialized
GELOCATIL GRIPE FORTE CON FENILEFRINA POLVO PARA SOLUCION ORAL
66302
POLVO PARA SOLUCIÓN ORAL
Sin Receta
Not Commercialized
PARACETAMOL EDIGEN 500 MG COMPRIMIDOS EFERVESCENTES EFG
83845
COMPRIMIDO EFERVESCENTE
Sin Receta
Not Commercialized
PARACETAMOL/FENILEFRINA/CLORFENAMINA GOBENS 500 MG/10 MG/4 MG CAPSULAS DURAS
Laboratorios Normon S.A.
82756
CÁPSULA DURA
Sin Receta
Not Commercialized
TRAMADOL/PARACETAMOL SANDOZ 37,5 mg/325 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Sandoz Farmaceutica S.A.
74080
COMPRIMIDO RECUBIERTO CON PELÍCULA
Medicamento Sujeto A Prescripción Médica
Commercialized

Philippines FDA Drug Approvals

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License Number
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Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Registration Number
Dosage Form
Strength
Approval Date
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UK EMC Drug Information

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Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
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