West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

For OTC labeling, what amount of sodium requires a warning: "Ask a doctor before use if you have a sodium restricted diet"?

1. ≤5 mg

2. ≤20 mg

3. ≤35 mg

4. ≥140 mg

The correct answer is: ≤5 mg

The correct indication for the warning "Ask a doctor before use if you have a sodium restricted diet" is related to the sodium content in over-the-counter (OTC) products. According to FDA regulations, if a product contains sodium levels higher than a specific threshold, it is necessary to inform consumers who may be on a sodium-restricted diet. In this case, the warning is required for products that contain: - Sodium at 140 mg or greater per dosage. This is important because individuals following a sodium-restricted diet need to be aware of how much sodium they are consuming from various products, including OTC medications. Products with sodium content above this threshold may significantly contribute to overall sodium intake and could pose health risks for those who need to limit their sodium consumption. Thus, the statement about asking a doctor before use is appropriately connected to sodium content of 140 mg or more, making that the level at which a warning is necessary for consumers.