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This 28-day rule comes from United States Pharmacopeia (USP) guidelines for multiple-dose vials containing antimicrobial preservatives

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Asymptomatic status: Document that the patient has no current symptoms of viral hepatitis or other viral disease

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It is approved by the United States Food and Drug Administration (FDA) for the treatment of excessive mucus secretions and for treatment of acetaminophen (Tylenol) overdose