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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

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/15
Phase 4
Recruiting
2025/06/12
Phase 3
Not yet recruiting
2025/06/04
Not Applicable
Active, not recruiting
2025/05/30
Phase 4
Not yet recruiting
2025/05/29
Phase 3
Not yet recruiting
2025/05/02
Phase 1
Recruiting
2025/04/30
Phase 4
Not yet recruiting
2025/04/29
Phase 3
Completed
Zitelli & Brodland Skin Cancer Center
2025/04/11
Phase 4
Not yet recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
2025/04/09
Phase 1
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Northwind Pharmaceuticals, LLC
51655-910
ORAL
300 mg in 1 1
6/14/2023
DIRECT RX
61919-023
ORAL
300 mg in 1 1
3/29/2023
Granules Pharmaceuticals Inc.
70010-670
ORAL
325 mg in 1 1
3/7/2024
Physicians Total Care, Inc.
54868-0378
ORAL
120 mg in 5 mL
11/10/2010
BI-MART
37835-525
ORAL
650 mg in 30 mL
5/1/2025
Akorn
50383-338
ORAL
240 mg in 10 mL
5/25/2022
Altura Pharmaceuticals, Inc.
63874-201
ORAL
650 mg in 1 1
4/28/2010
Genexa Inc.
69676-0089
ORAL
160 mg in 5 mL
5/23/2025
NUVICARE LLC
84324-019
ORAL
325 mg in 1 1
5/20/2025
Apotheca, Inc.
12634-537
ORAL
650 mg in 1 1
3/11/2010

EMA Drug Approvals

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

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
PARATAB TABLET 500 mg
SIN07062P
TABLET
500 mg
6/13/1992
PANADOL COLD RELIEF PSE CAPLET
Aspen Pharma Pty Ltd
SIN09985P
TABLET
500 mg
9/3/1998
PARACETAMOL KABI SOLUTION FOR INFUSION 10MG/ML
SIN15443P
INFUSION, SOLUTION
10mg/ml
3/8/2018
PROGESIC-250 SUSPENSION 250 mg/5 ml
SIN06068P
SUSPENSION
250 mg/5 ml
5/20/1991
PORO Suppository 250mg
SIN13754P
SUPPOSITORY
250mg
1/19/2010
PACOFEN TABLETS
SIN06271P
TABLET
500 mg
5/7/1991
PAMOL 650 TABLET 650MG
SIN15037P
TABLET
650MG
6/22/2016
NAPA 250 SUPPOSITORY 250 mg
SIN10522P
SUPPOSITORY
250 mg
12/8/1998
TYLENOL FILM COATED TABLETS 500MG
SIN15949P
TABLET, FILM COATED
500MG
6/6/2020
CALPOL SUSPENSION 120 mg/5 ml
Aspen Bad Oldesloe GmbH
SIN06062P
SUSPENSION
120 mg/5 ml
5/27/1991

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Paracetamol Dispersible Tablets
国药准字H20010494
化学药品
片剂
2/6/2020
Paracetamol Dispersible Tablets
国药准字H20000038
化学药品
片剂
3/10/2020
对乙酰氨基酚混悬滴剂
国药准字H19990007
化学药品
混悬滴剂
12/17/2019
Paracetamol Chewable Tablets
国药准字H20084015
化学药品
片剂
5/12/2023
Paracetamol Chewable Tablets
国药准字H10950188
化学药品
片剂(咀嚼)
11/22/2020
Paracetamol Chewable Tablets
国药准字H20043147
化学药品
片剂
4/14/2020
Paracetamol Chewable Tablets
国药准字H10940159
化学药品
片剂(咀嚼片)
7/7/2020
Paracetamol Tablets
国药准字H62021214
化学药品
片剂
4/10/2020
Paracetamol Sustained-release Tablets
国药准字H20010394
化学药品
片剂(缓释)
4/2/2024
Paracetamol Sustained-release Tablets
国药准字H19990360
化学药品
片剂
6/1/2020
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