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  1. Special Features

How FDA strives to ensure the safety of OTC products

Woman looking at over the counter drug labels

By Pat Clarke, Division of Online Communications

How much of a cold medicine can you safely take? Reading the Drug Facts label of your over-the-counter (OTC) drug product can help answer that question and many others. FDA regulations ensure that OTC drugs are safe and that the labels are easy to understand. OTC drugs can be bought and used safely without the need for a prescription.  

All OTC drug products have to meet FDA quality, effectiveness, and safety standards. While easier to obtain and use than prescription drugs, it is important to understand that these products are medicines and not without risks. Before using any medicine you should think through the benefits and the risks to make the best choice for you. Review the products and ask yourself:

  • What is the purpose of this drug?
  • Should I use the product?
  • Is there the possibility of interactions with other drugs or with foods?
  • What are the possible side effects?
  • When should I stop taking the medicine and contact a doctor?
  • How much of the medicine should I take?
  • How do I take it, how often, and how long?

Using just the label

Using only the Drug Facts label, a consumer should be able to decide if the product is right for them, follow usage directions and understand any warnings. “It is very important for consumers to read all of the information on the label to be sure that they are making a correct choice to take the medicine and properly following the directions for use,” said Dr. Andrea Leonard-Segal, director, Division of Nonprescription Clinical Evaluation, FDA.

Many OTC drugs on market

There are many different types of OTC products. These include pain relievers and fever reducers; antiperspirants; cough and cold medicines; toothpastes with fluoride; emergency contraceptives; weight loss medicine; heartburn medicines; acne remedies; hair re-growth solutions; and sunscreens, to name a few. Most cough and cold medicines are OTC products.

Different Paths to FDA Approval

An OTC product sometimes begins as an approved prescription drug. After there is enough post-marketing information about the safety of the medicine, sometimes a drug company will submit an application to switch the prescription product to over-the-counter. “The FDA performs a careful review of everything we already know about the medicine and also asks the company to provide any new information that we feel is necessary to know about the drug before it can be switched to over-the-counter,” said Leonard-Segal.

A few drugs get direct over‑the‑counter approval. These products have often been approved in foreign markets so post‑marketing safety data is available for FDA to examine.

Most OTC products are marketed through the OTC drug monograph system. An OTC drug monograph states such things as what kind of ingredients may be used to treat certain symptoms or conditions without a prescription, and the appropriate dose and instructions for use. OTC products that meet a monograph’s requirements may be marketed without FDA review.

Regardless of the pathway that supports the marketing of an OTC drug, it must meet the same effectiveness standards that prescription drugs meet. The safety standards for an OTC drug can be even higher than those that may support the marketing of a prescription drug. To further ensure the safe use of OTC products, FDA conducts studies to learn if potential OTC consumers understand the Drug Facts label, can properly choose the medicine for their needs, and use it according to the directions.

Read the label

The Drug Facts label includes all information necessary for the proper and safe use of the drug product. “It is very important to read the entire Drug Facts label and to not throw it away after you get home. Information about the safe and proper use should be available at all times with the medicine,” said Leonard-Segal. “This will ensure that you and other family members can get the most benefit from using the OTC medicine with the least possible risk.”

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