<span>An over-the-counter drug ingredient not generally recognized as safe or effective for the claimed therapeutic indication is classified as CATEGORY II.
Category II is part of the 3 categories that the over-the-counter drug review classify each drug based on its active ingredients.
Here are the categories and its specifications:
</span><span>Category I: generally recognized as safe and effective for the claimed therapeutic indication
Category II: not generally recognized as safe and effective or unacceptable indications
<span>Category III: insufficient data available to permit final classification
</span></span>
Only OTC drugs classified under Category I is guaranteed as safe by the government.
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