West Virginia MPJE (Pharmacy Jurisprudence) Practice Exam

For OTC labeling, what amount of calcium 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. ≥600 mg

The correct answer is: ≥20 mg

The correct answer is that for OTC (over-the-counter) labeling, a product must include the statement "each (insert appropriate dosage unit) contains: (insert names of ingredients in alphabetical order and the quantity of each ingredient)" if it contains 20 mg or more of calcium. This requirement is established to ensure that consumers are adequately informed about the contents of OTC products, particularly those that involve essential nutrients like calcium. When products contain significant amounts of active ingredients, the FDA mandates clear labeling to help consumers make informed decisions about their health and supplement intake. This threshold ensures that products containing clinically relevant amounts of calcium, which could impact daily intake and health outcomes, are recognized as needing detailed ingredient information. The requirement reflects a balance between providing necessary information while avoiding overwhelming consumers with details on products that contain negligible amounts of such ingredients. The other thresholds provided do not trigger this specific statutory labeling requirement because they fall below the established limit that the FDA has determined necessitates consumer awareness of ingredient composition.