West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

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

1. ≥20 mg

2. ≥8 mg

3. ≥5 mg

4. ≥975 mg

The correct answer is: ≥20 mg

The requirement for over-the-counter (OTC) labeling regarding magnesium states that if a product contains 20 mg or more of magnesium per dosage unit, it must include a specific labeling statement. This provision is in place to ensure that consumers are informed about the presence and quantity of key ingredients in the product. When magnesium is present in amounts meeting or exceeding this threshold, the label must include a statement detailing the exact quantity of magnesium, along with other active ingredients, listed in alphabetical order. Such regulations are designed to promote transparency and safety in OTC medications, allowing users to make informed decisions based on the active components contained in the product. The other options represent quantities that do not trigger this specific labeling requirement, focusing instead on lower concentrations which are not significant enough to necessitate detailed disclosure in this manner. Understanding these labeling requirements is essential for compliance and for ensuring that consumers are adequately informed about what they are ingesting.