Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

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What is the minimum dosage of sodium in an OTC drug that requires it to be labeled?

1 mg
5 mg
10 mg
15 mg

The correct answer is: 5 mg

The requirement for labeling sodium content in over-the-counter (OTC) drugs is based on safety regulations aimed at consumers who may be on sodium-restricted diets or who need to monitor their sodium intake for health reasons. According to the regulations, products containing sodium must include labeling when the sodium content is 5 milligrams or more per dosage unit. This threshold is established to inform consumers adequately without overwhelming them with information about very low sodium levels, which are typically not a health concern. Therefore, 5 mg is the minimum dosage that necessitates sodium labeling in OTC medications, ensuring consumer safety and compliance with health guidelines.