Information about the safe and proper use should be available at all times with the medicine,” said Leonard-Segal. “It is very important to read the entire Drug Facts label and to not throw it away after you get home. The Drug Facts label includes all information necessary for the proper and safe use of the drug product. ![]() 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. The safety standards for an OTC drug can be even higher than those that may support the marketing of a prescription drug. Regardless of the pathway that supports the marketing of an OTC drug, it must meet the same effectiveness standards that prescription drugs meet. OTC products that meet a monograph’s requirements may be marketed without FDA review. 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. ![]() Most OTC products are marketed through the OTC drug monograph system. These products have often been approved in foreign markets so post‑marketing safety data is available for FDA to examine. “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.Ī few drugs get direct over‑the‑counter approval. 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. Different Paths to FDA ApprovalĪn OTC product sometimes begins as an approved prescription drug. Most cough and cold medicines are 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. There are many different types of OTC products. Andrea Leonard-Segal, director, Division of Nonprescription Clinical Evaluation, FDA. “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. ![]() 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. How do I take it, how often, and how long?.How much of the medicine should I take?.When should I stop taking the medicine and contact a doctor?. ![]() Is there the possibility of interactions with other drugs or with foods?.Before using any medicine you should think through the benefits and the risks to make the best choice for you. While easier to obtain and use than prescription drugs, it is important to understand that these products are medicines and not without risks. OTC drugs can be bought and used safely without the need for a prescription.Īll OTC drug products have to meet FDA quality, effectiveness, and safety standards. FDA regulations ensure that OTC drugs are safe and that the labels are easy to understand. 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. By Pat Clarke, Division of Online Communications
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