What are the active ingredients in Tylenol (Acetaminophen) 3, also known as Tylenol with Codeine (Acetaminophen and Codeine)?

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Last updated: May 24, 2025View editorial policy

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From the Guidelines

Tylenol 3 contains acetaminophen (300 mg) and codeine phosphate (30 mg), making it a prescription medication used to treat moderate to moderately severe pain. The acetaminophen component works by reducing fever and blocking pain signals in the brain, while codeine is an opioid that changes how your body senses pain 1. Each tablet also contains inactive ingredients to form the pill. Tylenol 3 is stronger than regular Tylenol due to the addition of codeine, making it a controlled substance with potential for dependence.

Key Components and Considerations

  • The medication is used for treating moderate to moderately severe pain
  • Acetaminophen reduces fever and blocks pain signals in the brain
  • Codeine is an opioid that alters the body's perception of pain
  • Potential side effects include drowsiness, constipation, nausea, and dizziness
  • Maximum daily dose of acetaminophen should not exceed 4000 mg to avoid liver damage
  • Patients should be aware that the medication may impair driving ability or operation of machinery

Important Precautions

  • Codeine is a prodrug that requires metabolism by CYP2D6 to active metabolites for effective analgesia 1
  • Inhibitors of CYP2D6 may reduce the effectiveness of codeine
  • Use with caution in patients with renal insufficiency, as codeine and its metabolites can accumulate 1
  • Methadone, another opioid, should be used with caution due to its potential for accumulation and risk of QTc prolongation 1

From the FDA Drug Label

ACTIVE INGREDIENT (IN EACH CAPLET) Acetaminophen USP, 650 mg The main ingredient in Tylenol 3 is Acetaminophen, with a dose of 650 mg per caplet, according to the drug label 2.

From the Research

Ingredients in Tylenol 3

  • Tylenol 3 is a combination medication that contains acetaminophen and codeine 3
  • Acetaminophen is a pain reliever and fever reducer, while codeine is an opioid cough suppressant and pain reliever
  • The specific ingredients in Tylenol 3 may vary depending on the formulation, but it typically contains 300mg of acetaminophen and 15mg or 30mg of codeine per tablet

Pharmacological Effects

  • Acetaminophen works by inhibiting the production of prostaglandins in the brain, which are chemicals that cause pain and fever 4
  • Codeine works by binding to opioid receptors in the brain and spinal cord, which helps to reduce pain perception 5
  • The combination of acetaminophen and codeine in Tylenol 3 provides relief from moderate to severe pain, such as headaches, toothaches, and muscle aches

Safety and Efficacy

  • Tylenol 3 is generally considered safe and effective when used as directed, but it can cause side effects such as drowsiness, dizziness, and nausea 6
  • Long-term use of Tylenol 3 can lead to dependence and addiction, especially with the codeine component 7
  • It is essential to follow the recommended dosage and consult with a healthcare professional before taking Tylenol 3, especially if you have a history of substance abuse or are taking other medications.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Pharmacologic Therapy for Acute Pain.

American family physician, 2021

Research

A systematic review on the effectiveness of pharmacological interventions for chronic non-specific low-back pain.

European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2011

Research

Muscle Relaxants for Acute and Chronic Pain.

Physical medicine and rehabilitation clinics of North America, 2020

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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