According to the FDA, an active ingredient is any component of a drug product intended to provide therapeutic and pharmacological activity in direct effect to a diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans. Active ingredients include those components of the product that may undergo chemical change during the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect. An inactive ingredient is any component of a drug product other than the active ingredients.

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