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In fact, a United States prospective cohort study[14] showed that 6% of patients with an acute combination medication overdose of paracetamol with antihistamines or opioids had paracetamol levels that were initially low at the 4-hour time mark but were later found to be above the 150 g/mL treatment threshold

Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval

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