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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
2015/08/17
Phase 4
Completed
2015/08/10
Phase 4
Completed
2015/08/04
Phase 1
Completed
University Medicine Greifswald
2015/08/03
Phase 4
UNKNOWN
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
2015/07/22
Phase 4
UNKNOWN
2015/07/22
Not Applicable
Completed
2015/07/15
Phase 4
Terminated
2015/07/13
Phase 2
Completed
2015/07/01
Not Applicable
Completed
2015/06/22
Phase 3
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Endo Pharmaceuticals Inc.
63481-628
ORAL
325 mg in 1 1
7/12/2022
West-Ward Pharmaceuticals Corp
0054-8648
ORAL
325 mg in 5 mL
8/12/2016
RPK Pharmaceuticals, Inc.
53002-0101
ORAL
300 mg in 1 1
10/21/2021
PharmPak, Inc.
54348-015
ORAL
300 mg in 1 1
1/11/2015
Meijer Distribution Inc
41250-603
ORAL
325 mg in 15 mL
9/19/2025
A-S Medication Solutions
50090-4064
ORAL
325 mg in 1 1
7/28/2018
Amazon.com Services LLC
72288-544
ORAL
650 mg in 1 1
5/10/2025
Rhodes Pharmaceuticals L.P.
42858-102
ORAL
325 mg in 1 1
1/2/2024
KROGER COMPANY
41226-675
ORAL
325 mg in 1 1
5/23/2025
Mayne Pharma Inc.
68308-220
ORAL
325 mg in 1 1
1/9/2024

EMA Drug Approvals

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Status
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No EMA approvals found for this drug.

HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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Company
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Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ACETAMINOPHEN SOLUTION ORAL GTTE 80MG/ML USP
laboratoires trianon inc.
01905864
Drops - Oral
80 MG / ML
12/31/1991
INFANTS' FEVER FROM COLDS OR FLU
perrigo international
02371111
Suspension - Oral
80 MG / ML
N/A
INFANTS TYLENOL COLD SUSPENSION DROPS
mcneil consumer healthcare division of johnson & johnson inc
02182424
Suspension - Oral
80 MG / ML
8/11/1997
JAMP ACETAMINOPHEN FILM COATED TABLETS
02382261
Tablet - Oral
325 MG
N/A
JUNIOR STRENGTH TYLENOL COMPLETE COLD, COUGH & FEVER
mcneil consumer healthcare division of johnson & johnson inc
02371073
Tablet (Chewable) - Oral
160 MG
10/19/2011
HELP I HAVE A HEADACHE
help remedies inc
02375125
Tablet - Oral
325 MG
N/A
DAY TIME LIQUID CAPS
ivax pharmaceuticals incorporated
02247785
Capsule - Oral
250 MG
N/A
CHILDREN'S CHEWABLE ACETAMINOPHEN 80MG TABLETS
westcan pharmaceuticals ltd.
02237678
Tablet - Oral
80 MG / TAB
N/A
CHILDREN'S TYLENOL COMPLETE COLD, COUGH & FEVER NIGHTTIME
mcneil consumer healthcare division of johnson & johnson inc
02416050
Suspension - Oral
160 MG / 5 ML
6/15/2014
DAYTIME COLD & FLU LIQUID CAPSULES
vita health products inc
02258919
Capsule - Oral
325 MG
1/10/2005

CIMA AEMPS Drug Approvals

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Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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