West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

For OTC labeling, what amount of potassium requires the statement "each (insert appropriate dosage unit) contains: (insert names of ingredients in alphabetical order and the quantity of each ingredient)"?

1. ≥8 mg

2. ≥5 mg

3. ≥975 mg

4. ≥20 mg

The correct answer is: ≥8 mg

The requirement for including a statement on OTC labeling indicating the amount of potassium present is triggered when the potassium content is 975 mg or more per dosage unit. If the potassium content is lower, specifically below this threshold, this statement is not necessary. This regulation is in place to ensure that consumers are aware of significant amounts of potassium, as excessive intake can have health implications, particularly for individuals with certain medical conditions. Choosing an amount of 8 mg or even 5 mg does not align with the regulatory requirements, as these amounts are significantly lower than the threshold set for mandatory labeling of potassium content in OTC products. Therefore, the assertion that ≥8 mg necessitates such labeling is incorrect. The regulations are stringent in specifying higher thresholds to ensure that only those products containing substantial quantities advise consumers adequately about their potassium content.