What are the labeling requirements for over-the-counter drugs?

The label on a drug is there to inform a patient of what medicine is supposed to do and how it can be used for the desired results. The effectiveness of pharmaceutical labeling can make a huge difference to the success of a product, ensuring it is used correctly by providing the right information to customers. When it comes to over-the-counter (OTC) medication, the guidance on the packaging is even more important than prescription medication since the buyer is the one responsible for selecting the right drug and using it correctly by following the instructions.

The label is legally obliged to contain important information which covers everything from the ingredients used to the safety information, following a standardized layout so customers can get used to the consistent label designs. The U.S. Food and Drug Administration (FDA) has issued a regulation to ensure the labels on all over-the-counter medicines have key pieces of information listed in the same order, using a standardized style that is proven to be easy to use for customers when browsing different product options.

The current requirements mean all over-the-counter medication follows the same layout and information pieces, with a standard label consisting of the following details:

  • Purpose
    A summary of the product and the category which the drug falls into, helping shoppers quickly identify it when browsing the shelf.
  • Uses
    A description of the symptoms or medical condition that the product is designed to treat or prevent.
  • Ingredients
    A comprehensive list of the active substances in a product as well as the inactive ingredients which consist of extras such as colors or flavors.
  • Directions
    Clear and concise instructions for use which include how to take the medication, how often it should be consumed, and how to measure the correct dosages.
  • Warnings
    Certain conditions may require advice from a doctor before taking the product and this should be made clear if applicable. Any possible side effects should also be listed alongside information on when to stop taking the product and seek guidance from a medical professional should they occur.
  • Storage
    Instruction on how to store the product properly to avoid impacting its effectiveness should be available to ensure it remains safe to use.

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