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Draft Guidance Drills Down With Details To Cut Pediatric Acetaminophen Overdose Risk

 
• By Elizabeth Crawford

FDA suggests new and repeats previous recommendations to reduce the risk of pediatric overdose with acetaminophen products due either to unsupervised ingestion or therapeutic errors. The guidance includes greater detail on delivery devices and labeling information for pediatric acetaminophen OTCs.

FDA recommends OTC drug firms include appropriate dosage devices with liquid acetaminophen pediatric products and add flow restrictors to containers to further reduce the risk of accidental overdose or unsupervised ingestion.

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