West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

For OTC labeling, what amount of potassium requires the statement "ask a doctor before use if you have kidney stones or calcium-restricted diet"?

1. >600 mg

2. >975 mg

3. >3.2 g

4. ≥5 mg

The correct answer is: >600 mg

The requirement for the statement regarding potassium on OTC labeling is specifically dictated by the amount of potassium present in the medication. When an OTC product contains more than 600 mg of potassium per dosage unit, it necessitates a warning that advises consumers to consult a doctor before use if they have kidney stones or are on a calcium-restricted diet. This regulation is intended to safeguard individuals who may be at risk due to their health conditions, as high potassium levels can exacerbate certain medical issues. The other amounts listed do not trigger this specific warning. Options like 975 mg and 3.2 g are both above the threshold of 600 mg, but in the context of this regulation, they are beyond what is immediately necessary for labeling. The option indicating "≥5 mg" is significantly below the threshold, as it does not account for the health implications associated with larger amounts of potassium. Hence, the requirement for the warning stems from the recognized health risks associated with higher potassium intake, particularly at levels exceeding 600 mg.