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Label indications:

Medication that have label indications mean that they were approved by the FDA. This means that they are clinically significance for the indication and manufactures are allowed to market their drug for the indication. A drug can have more than one FDA labeled indication, this means they can be used for multiple medical conditions.

Off-label indications:

Off-label indications are drugs that are used for medical indications that have not been approved by the FDA. Off label indications often have some clinical papers to back the use, but they have not gone through the extensive testing required by the FDA to have an official labeled indication. Drug companies can not provide any official medication information (e.g package inserts) for off label indications.