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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
2023/01/10
Phase 4
Recruiting
2022/12/12
Phase 1
Not yet recruiting
2022/12/07
Phase 4
ENROLLING_BY_INVITATION
2022/11/25
Phase 3
Active, not recruiting
2022/11/23
Not Applicable
Recruiting
2022/11/03
Phase 3
Active, not recruiting
2022/11/01
Phase 4
Completed
2022/10/28
Phase 2
Recruiting
2022/10/04
Phase 1
Completed
Nanjing Children's Hospital
2022/10/03
Not Applicable
Recruiting

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
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
SpecGx LLC
0406-0123
ORAL
325 mg in 1 1
1/3/2024
RedPharm Drug, Inc.
67296-1791
ORAL
325 mg in 1 1
1/21/2022
Proficient Rx LP
71205-981
ORAL
325 mg in 1 1
10/1/2023
NuCare Pharmaceuticals,Inc.
68071-4657
ORAL
325 mg in 1 1
2/17/2021
Upsher-Smith Laboratories, LLC
0245-0410
ORAL
325 mg in 1 1
7/6/2023
West-Ward Pharmaceuticals Corp
0054-3686
ORAL
325 mg in 5 mL
8/12/2016
NuCare Pharmaceuticals,Inc.
68071-2932
ORAL
325 mg in 1 1
2/28/2023
DIRECT RX
72189-256
ORAL
325 mg in 1 1
10/24/2023

EMA Drug Approvals

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Approved Product
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
Paracetamol for Suspension
国药准字H19990202
化学药品
口服混悬剂
4/13/2020
Paracetamol for Suspension
国药准字H20010057
化学药品
干混悬剂
6/12/2020
Paracetamol for Suspension
国药准字H20053008
化学药品
口服混悬剂
4/13/2020
Pediatric Paracetamol Enema
国药准字H43021895
化学药品
外用溶液剂
2/15/2020
Pediatric Paracetamol Enema
国药准字H13024063
化学药品
溶液剂
10/18/2020
Pediatric Paracetamol Enema
国药准字H34023721
化学药品
溶液剂
11/19/2020
Pediatric Paracetamol Enema
国药准字H34023720
化学药品
溶液剂
11/19/2020
Pediatric Paracetamol Enema
国药准字H44024738
化学药品
溶液剂
8/13/2020
Pediatric Paracetamol Enema
国药准字H23022997
化学药品
溶液剂
8/6/2020
Pediatric Paracetamol Enema
国药准字H21022831
化学药品
溶液剂
7/23/2020

PPB Drug Approvals

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TGA Drug Approvals

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