§ 111400 Misbranded Dangerous Drugs

• •If a medicine or medical tool is unsafe when used exactly as the label says, it's considered misbranded.
• •This includes being unsafe because of how much you take, how often you take it, or how long you use it.
• •The label must give safe instructions for use.

A cough syrup label says to take 2 spoonfuls every 4 hours, but taking that amount causes serious health problems.

The cough syrup is misbranded because following the label’s instructions makes it unsafe.