An over-the-counter (OTC) can be purchased without a prescription. These drugs must meet certain criteria to be sold.


(1) easier access to drugs

(2) cheaper access to drugs


Key criteria:

(1) generally recognized as safe and effective

(2) relatively safe if taken according to the instructions

(3) low potential for misuse



(1) meet regulatory approval (either meet the requirements outlined in an OTC monograph or have been been submitted to the FDA)

(2) all ingredients listed

(3) properly labeled


Just because a drug is over-the-counter does not mean:

(1) that the drug is safe if taken in a manner inconsistent with instructions

(2) that the drug is not potentially addictive

(3) that the drug will not interact with other medications

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