Arkansas Pharmacy Laws and Regulations Practice Exam

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What is the dose limit and package size for exempted pediatric (age <2) PSE formulation?

NTE 2mL/dose or 0.5 fl oz per package
NTE 2mL/dose or 1 fl oz per package
NTE 3mL/dose or 1.5 fl oz per package
NTE 1mL/dose or 0.5 fl oz per package

The correct answer is: NTE 2mL/dose or 1 fl oz per package

According to guidelines, the maximum dose limit for exempted pediatric (age <2) PSE formulations is 2mL per dose. However, the package size may vary. Option A and D both have a package size of 0.5 fl oz, which is incorrect as it exceeds the maximum allowed size of 1 fl oz. Option C has a larger package size of 1.5 fl oz, which also exceeds the limit. This leaves option B as the correct answer, with a maximum dose limit of 2mL and a package size of 1 fl oz. This ensures safe usage for young children while still providing an adequate amount of medicine for them.