South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which component is NOT required on an OTC drug facts label?

1. Active ingredients

2. Expiration date

3. Purpose

4. Use

The correct answer is: Expiration date

The component that is not required on an OTC drug facts label is the expiration date. While the FDA's regulations do require that over-the-counter (OTC) drug products include essential information to ensure user safety and product effectiveness, the expiration date is not mandated as part of the Drug Facts label itself. The Drug Facts label is designed to provide consumers with critical information about the product's active ingredients, purpose, dosage instructions, uses, warnings, and other relevant details. Including an expiration date is important for ensuring product stability and safety, but it is typically placed on the packaging rather than as a required element of the Drug Facts label. Packaging must have an expiration date to be in compliance with regulations, but it does not need to be listed within the Drug Facts section. This distinction highlights the distinction between what is necessary for labeling compliance versus what is needed for proper consumer guidance within the official labeling requirements set by the FDA.