West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

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

1. ≥20 mg

2. ≥8 mg

3. >600 mg

4. >3.2 g

The correct answer is: ≥20 mg

The requirement for the statement "ask a doctor before use if you have kidney stones or calcium-restricted diet" on OTC labeling specifically pertains to the amount of magnesium present in the product. When magnesium is present in amounts of 20 mg or more, this advisory statement is necessary to ensure consumer safety, particularly for individuals with specific health conditions such as kidney stones or those who follow a calcium-restricted diet. This guideline is established to help prevent potential health risks, as excessive magnesium can impact individuals with compromised kidney function or those managing calcium intake for health reasons. Therefore, any magnesium-containing OTC product that provides 20 mg or more must include this warning to inform consumers about the possible implications for their health. This makes it crucial for such products to have comprehensive labeling that addresses these concerns. It is important to note that lower amounts than 20 mg do not trigger this requirement, as they are generally considered safe for the average consumer without the outlined health conditions.