From the FDA Drug Label
Warnings Liver warning This product contains acetaminophen Severe liver damage may occur if: ... a child takes more than 5 doses in 24 hours The FDA drug label does not answer the question.
From the Research
The toxic dose of paracetamol in children is generally considered to be more than 200 mg/kg body weight as a single ingestion, or more than 75 mg/kg/day for multiple days, posing a significant risk for hepatotoxicity and requiring medical evaluation. When considering the potential for toxicity, it's crucial to understand that paracetamol's therapeutic dosing for children is typically 10-15 mg/kg per dose, with a maximum of 75 mg/kg/day not to exceed 4000 mg daily 1. Paracetamol toxicity occurs because the liver's detoxification pathways become saturated at high doses, leading to the accumulation of a toxic metabolite (NAPQI) that depletes glutathione and causes hepatocellular damage 2. Key points to consider include:
- Early symptoms of toxicity may be minimal or nonspecific, including nausea, vomiting, and abdominal pain, while liver damage typically manifests 24-48 hours after ingestion.
- Any suspected overdose requires immediate medical attention for assessment and possible treatment with N-acetylcysteine, which is most effective when administered within 8 hours of ingestion 3.
- Pediatric drug metabolism differs from adult metabolism, with children having a larger liver size compared to their body weight, resulting in a higher metabolism rate, but they seem to be less sensitive to acute intoxication than adults 2.
- The treatment of choice for paracetamol poisoning is N-acetylcysteine, a specific antidote that reduces paracetamol hepatotoxic effects, and should be given according to specific regimens through weight-based dosing tables 3.