Ibuprofen sold in an immediate release dosage form containing 400 mg or less per oral dosage unit exceeding 18,000 mg is categorized as?

Ibuprofen, when sold in an immediate release dosage form containing 400 mg or less per oral dosage unit, is categorized as Schedule 3 when the maximum total quantity exceeds 18,000 mg. This categorization is significant because it determines the conditions under which the medication can be sold and the level of regulation it is subjected to.

Schedule 3 medications are typically those that may be sold without a prescription but are still subject to certain restrictions to ensure safe usage. The stipulation that the total quantity of ibuprofen exceeds 18,000 mg indicates that high volumes require monitoring to prevent misuse and to ensure consumer safety. This aligns with the principles of pharmacological safety, as higher quantities may lead to unintentional overdose or harmful effects.

The regulation of ibuprofen in this manner helps pharmacists and healthcare providers ensure that patients are using the medication appropriately and are aware of the risks associated with excessive consumption. This categorization reflects a need for balance between accessibility of over-the-counter medications and the protection of public health.