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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
2024/07/17
Phase 4
Not yet recruiting
2024/07/12
Phase 1
Recruiting
2024/07/03
Early Phase 1
Completed
United States Naval Medical Center, San Diego
2024/06/28
Phase 4
Recruiting
2024/06/27
Phase 4
Completed
2024/06/21
Phase 1
Recruiting
2024/06/14
Phase 1
Completed
2024/05/30
Phase 4
Recruiting
2024/05/28
Not Applicable
Not yet recruiting
2024/05/16
Phase 2
Recruiting
Kasr El Aini Hospital

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
NuCare Pharmaceuticals,Inc.
68071-5201
ORAL
325 mg in 1 1
2/7/2022
Unit Dose Services
50436-3918
ORAL
325 mg in 1 1
8/7/2018
Bryant Ranch Prepack
63629-2293
ORAL
325 mg in 1 1
3/19/2021
Rebel Distributors Corp.
21695-271
ORAL
750 mg in 1 1
2/10/2010
A-S Medication Solutions
50090-3011
ORAL
300 mg in 1 1
12/28/2023
AvPAK
50268-553
ORAL
325 mg in 1 1
8/29/2022
ATLANTIC BIOLOGICALS CORP.
17856-1122
ORAL
160 mg in 5 mL
5/12/2025
A-S Medication Solutions
50090-0919
ORAL
325 mg in 1 1
11/28/2019
Bryant Ranch Prepack
63629-2190
ORAL
325 mg in 1 1
4/26/2019
Graviti Pharmaceuticals Private Limited
69844-049
ORAL
325 mg in 1 1
7/15/2020

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
COLDSOFT DAY SOFT GELATIN CAPSULE
SIN13321P
CAPSULE, GELATIN COATED
275.00MG
7/31/2007
PANADOL WITH OPTIZORB CAPLET 500MG
Sterling Drug (Malaya) Sdn Bhd, Granules India Limited (Granulate)
SIN14699P
TABLET, FILM COATED
500 mg
12/17/2014
PARACETAMOL B. BRAUN SOLUTION FOR INFUSION 10MG/ML
SIN14786P
INFUSION, SOLUTION
1.00g/100ml
5/19/2015
PANADOL TABLET 500 mg
STERLING DRUG (MALAYA) SDN BHD
SIN05919P
TABLET
500 mg
5/23/1991
SUNNY PARACETAMOL TABLET 500 mg
SIN06174P
TABLET
500mg
5/8/1991
PARMOL 250 SUSPENSION 250 mg/5 ml
SIN05565P
SUSPENSION
250 mg/5 ml
3/20/1991
PORO SUSPENSION (ORANGE FLAVOUR) 250MG/5ML
SIN16140P
SUSPENSION
250mg/5ml
3/29/2021
ACET 325 SUPPOSITORIES 325 mg
SIN10641P
SUPPOSITORY
325 mg
1/7/1999
DOLO TABLETS 500 mg
SIN11052P
TABLET
500 mg
7/29/1999
WATSONS PAIN & FEVER RELIEF TABLET 500MG
SIN16262P
TABLET
500 mg
7/5/2021

NMPA Drug Approvals

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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

Health Canada Drug Approvals

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Approved Product
Company
DIN
Dosage Form
Strength
Market Date
COLD AND FLU MEDICINE - NIGHT TIME FORMULA
pharmetics (2011) inc
02271672
Capsule - Oral
325 MG
4/10/2006
DAY & NIGHT COMBO PACK
the winning combination inc.
02380331
Kit ,  Powder For Solution - Oral
500 MG / 4.6 G
N/A
CHILDREN'S TYLENOL COLD AND COUGH
mcneil consumer healthcare division of johnson & johnson inc
00870455
Tablet - Oral
80 MG
12/31/1990
COLD STIX
laboratoire riva inc.
02377861
Powder For Solution - Oral
325 MG / SACHET
10/10/2013
DAY & NIGHT COMBO PACK
the winning combination inc.
02380331
Kit ,  Powder For Solution - Oral
650 MG / 5 G
N/A
CHILDREN'S TYLENOL ALLERGY-D SUSPENSION
mcneil consumer healthcare division of johnson & johnson inc
02241043
Suspension - Oral
160 MG / 5 ML
6/15/2000
ACETAMINOPHEN 500MG
zakaria pharmaceutical group inc.
02238806
Tablet - Oral
500 MG / TAB
3/3/1999
HOT LEMON RELIEF POWDER EXTRA STRENGTH
02248704
Powder - Oral
650 MG / 22 G
N/A
ACETAMINOPHEN CAPLETS EXTRA STRENGTH
tanta pharmaceuticals inc
01962353
Tablet - Oral
500 MG
12/31/1993
HOT LEMON ULTRA STRENGTH TOTAL FLU NIGHT
cellchem pharmaceuticals inc.
02504812
Powder For Solution - Oral
1000 MG / SACHET
N/A

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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License Number
Dosage Form
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
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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