South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which item is NOT required on the labeling of an OTC product's package?

1. Manufacturer's address

2. Directions for pediatric use

3. Purpose of the medication

4. Storage information

The correct answer is: Directions for pediatric use

The requirement for labeling on over-the-counter (OTC) products is guided by regulations set forth by the Food and Drug Administration (FDA) to ensure that consumers have essential information for safe and effective use of the medication. While it is critical to include certain information for all users, not all products are required to provide specific details for pediatric use. The purpose of including the manufacturer's address, directions for use, and storage information is to enhance product safety and efficacy. The manufacturer's address allows consumers to contact the company for inquiries or reports of adverse effects. Instructions for proper usage, including any necessary dosing information for all populations, are essential to avoid misuse and ensure that the medication is taken correctly. Likewise, storage information helps maintain the product’s integrity, ensuring it works as intended. Pediatric dosing instructions, while often included for many OTC medications, are not universally required. This is because not all OTC products are intended for use by children, and if they are intended only for adults, such guidance is not necessary. Therefore, the absence of pediatric use directions on certain OTC labeling is acceptable, making it the correct choice in this context.