What is the recommended dose of acetaminophen (paracetamol) for children?

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Acetaminophen Dosing in Children

The recommended dose of acetaminophen for children is 10-15 mg/kg per dose, administered every 4-6 hours, with a maximum of 5 doses per day (not exceeding 75 mg/kg/day or 4000 mg/day, whichever is lower). 1, 2

Standard Dosing Regimen

Single Dose

  • 10-15 mg/kg per dose is the evidence-based range that provides effective antipyretic and analgesic effects 3, 1, 2
  • Doses below 10 mg/kg have minimal antipyretic effect, while 20 mg/kg as a single dose is more effective than 10 mg/kg 3
  • A loading dose of 25 mg/kg followed by maintenance doses of 12.5 mg/kg every 6 hours can be used for optimal effect 3

Dosing Interval

  • Administer every 4-6 hours as needed 1, 2
  • Do not exceed 5 doses in 24 hours 2, 4

Maximum Daily Dose

  • 75 mg/kg/day for children, but never exceeding 4000 mg/day regardless of weight 2
  • In the UK and Australia, total daily doses range from 40-60 mg/kg/day divided into 4-6 hour intervals 2

Administration Considerations

Route of Administration

  • Oral suspension is preferred over suppositories due to more consistent absorption and response 3
  • For infants and young children, use an appropriate measuring device such as a 3-mL or 5-mL oral syringe for accurate measurement 5

Age-Specific Considerations

  • Acetaminophen is the only recommended analgesic for children under 3 months of age 6
  • Dosing schedules can be adapted to age-based or weight-based approaches, with weight-based being more accurate 1

Special Populations

Hepatic Impairment

  • Reduce doses and extend intervals in children with hepatic impairment to minimize hepatotoxicity risk 7

Renal Impairment

  • Standard dosing can generally be used, but monitor for accumulation in severe cases 7

Safety Considerations and Toxicity Prevention

Hepatotoxicity Risk

  • Single ingestions of more than 10 times the recommended dose (>140 mg/kg) are potentially toxic 2
  • Chronic exposures greater than 140 mg/kg/day for several days carry risk of serious liver toxicity and failure 8, 2
  • Overdose can result in liver and kidney failure, particularly with repeated supratherapeutic ingestions 8

Common Dosing Errors

  • In community practice, only 61% of parents administer appropriate doses, with 12% giving overdoses (≥20 mg/kg) and 27% giving underdoses (<10 mg/kg) 4
  • Proper parent education is essential to prevent inadequate or excessive administration 4

Combination Products

  • Exercise caution when using combination opioid-acetaminophen products to prevent excess acetaminophen dosing 9
  • The FDA has limited acetaminophen content in prescription combination products to 325 mg per dosage unit 8

Clinical Efficacy

Antipyretic Effect

  • Plasma concentrations of 4-18 mg/L are appropriate for antipyretic effect 3
  • More than 10 mg/kg is required to maintain temperature 1.5°C below baseline for 6 hours 3
  • Half-life is 1-3.5 hours in children 3

Analgesic Effect

  • Effective for mild to moderate pain in children 2, 6
  • Provides significant additive analgesic effect when combined with opiates for severe pain 2
  • Equivalent efficacy to aspirin at the same dose (10-15 mg/kg) 3

Second-Line Options

  • If acetaminophen is ineffective for fever management, ibuprofen may be considered as second-line treatment 5

References

Research

Pediatric dosing of acetaminophen.

Pediatric pharmacology (New York, N.Y.), 1983

Research

Paracetamol efficacy and safety in children: the first 40 years.

American journal of therapeutics, 2000

Research

[Optimal dose of acetaminophen in children].

Archives francaises de pediatrie, 1990

Guideline

Paracetamol Dosing and Administration in Children

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Paracetamol (acetaminophen) for chronic non-cancer pain in children and adolescents.

The Cochrane database of systematic reviews, 2017

Guideline

Acetaminophen Dosing Considerations for Pediatric Patients with Hepatic Impairment

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Maximum Recommended Acetaminophen Dose for Adults

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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