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Setting this precedent seriously jeopardizes public health and undermines the FDA's core responsibility to protect consumers

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Because the duration of opioid reversal is expected to be less than the duration of action of codeine in acetaminophen and codeine phosphate tablets, carefully monitor the patient until spontaneous respiration is reliably reestablished

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Preventive Measures to Avoid Future Denials Utilize checklists, train staff, and audit charts regularly