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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.

Background

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
2005/10/18
Phase 3
Completed
2005/10/18
Phase 4
Completed
2005/10/18
Phase 4
Completed
2005/09/21
Phase 3
Completed
2005/09/20
Not Applicable
Terminated
2005/09/16
Not Applicable
Completed
University Hospital, Angers
2005/09/16
Phase 2
Completed
2005/09/16
Phase 2
Completed
2005/09/09
Phase 3
Completed
2005/09/07
Phase 3
Terminated

FDA Approved Products

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Route
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Approved
NDC Code

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No FDA products found for this drug

EMA Approved Products

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EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

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No EMA products found for this drug

HSA Approved Products

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NMPA Approved Products

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Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import
国药准字H23021236
片剂(素片)
N/A
0.3g
Chemical Drug
Approved
2020/09/23
Domestic
国药准字H22020911
片剂
N/A
0.5g
Chemical Drug
Approved
2020/03/23
Domestic
国药准字H43022131
片剂
N/A
0.1g
Chemical Drug
Approved
2015/09/24
Domestic
国药准字H51020155
片剂
N/A
0.5g
Chemical Drug
Approved
2021/02/10
Domestic
国药准字H51022964
片剂(素片,薄膜衣片)
N/A
片剂(素片)
Chemical Drug
Approved
2016/01/07
Domestic
国药准字H14021605
片剂
N/A
0.3g
Chemical Drug
Approved
2020/08/27
Domestic
国药准字H43022132
片剂
N/A
0.5g
Chemical Drug
Approved
2022/12/19
Domestic
国药准字H37020067
片剂
N/A
0.3g
Chemical Drug
Approved
2015/06/23
Domestic
国药准字H13022470
片剂
N/A
0.3g
Chemical Drug
Approved
2020/07/22
Domestic
国药准字H14021337
片剂
N/A
0.5g
Chemical Drug
Approved
2020/04/20
Domestic

PPB Approved Products

Product Name
Registration Code
Company
Category
Sale Type
Reg. Date
HK-27985
unicorn laboratories o/b american unicorn laboratories limited
Part 2 Poison
OTC
1986/11/28
HK-50245
unicorn laboratories o/b american unicorn laboratories limited
Part 2 Poison
OTC
2002/10/18
HK-61400
Evercare Pharmaceutical Company Limited
Part 2 Poison
OTC
2012/09/07
HK-31209
Haleon Hong Kong Limited
Part 2 Poison
OTC
1988/11/24
HK-46476
unicorn laboratories o/b american unicorn laboratories limited
Part 2 Poison
OTC
2000/06/30
HK-46478
unicorn laboratories o/b american unicorn laboratories limited
Part 2 Poison
OTC
2000/06/30
HK-06328
unicorn laboratories o/b american unicorn laboratories limited
Part 2 Poison
OTC
1979/05/25
HK-43594
Haleon Hong Kong Limited
Part 2 Poison
OTC
1998/09/05
HK-64868
Evercare Pharmaceutical Company Limited
Part 2 Poison
OTC
2017/01/03
HK-50183
unicorn laboratories o/b american unicorn laboratories limited
Part 2 Poison
OTC
2002/09/30

TGA Approved Products

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