What is the requirement for an OTC package not designed to be child-resistant?

For an over-the-counter (OTC) package that is not designed to be child-resistant, the requirement is that it must state it is for households without young children. This regulation is in place to ensure that consumers are aware of the potential risks associated with the product not having child-resistant features. By explicitly stating that it is suitable for households without young children, it serves as an important warning and informs users to take necessary precautions regarding storage and accessibility.

This requirement emphasizes the need for manufacturers to communicate risks effectively, ensuring that those who may be most vulnerable to accidental ingestion—namely children—are adequately protected by informing consumers of the package's design features. It directs attention to the responsibility of adults to keep such medications out of reach from children which is a vital aspect of safety in pharmaceutical practices.

The other options, while related to packaging and safety, do not specifically address the regulatory requirement tied to the absence of a child-resistant design.