Which of the following is a required label item for Over-The-Counter (OTC) drugs?

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The required labeling item for Over-The-Counter (OTC) drugs is the drug facts title. This title is essential as it provides consumers with immediate access to important information about the medication. The "Drug Facts" label includes critical details such as active ingredients, uses, warnings, dosage instructions, and other pertinent information that helps consumers make informed decisions regarding their health.

Having a "Drug Facts" title is a regulatory requirement established by the FDA, ensuring that the information is standardized and clearly visible to aid the consumer in understanding the product. This requirement helps to ensure safety and efficacy, as it allows users to easily compare and review different medications based on their needs.

While dietary information, usage suggestions, and advertising disclaimers may be important in other contexts, they are not mandated elements of the labeling for OTC drugs. The focus of OTC drug labeling is primarily on the drug facts to guide the consumer effectively.

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