Over the Counter Medications
Drugs that are safe and effective for use by the general public without a prescription are defined as over-the-counter (OTC) drugs. These drugs are often located on shelves in pharmacies with easy access by patients, but may also be located in non-pharmacy outlets, such as grocery stores, convenience marts and large discount retailers. In the U.S. there are more than 80 classes of OTC drugs, ranging from allergy medicines to pain relievers to weight loss products.
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A restricted class of OTC drugs also exists in the U.S. This restricted class includes drugs such as pseudoephedrine, emergency contraception, and some Schedule V controlled substances. These products, while considered OTC, are kept behind the pharmacy counter and must be dispensed by a pharmacist pursuant to proper identification, age verification, and patient education. In March 2012, the FDA considered expanding the definition of nonprescription drugs to include cholesterol, blood pressure, asthma and birth control medications. This new Rx-to-OTC switch ruling is currently under review and commenting.
The U.S. Food and Drug Administration’s (FDA) Division of Drug Information (CDER) evaluates and reviews OTC ingredients and labels. An OTC drug monograph is established for each class of product. The monograph contains acceptable ingredients, doses, formulations, and labeling. New products that conform to an existing OTC drug monograph may be marketed without further FDA review. Those OTC products that do not conform to an OTC monograph must undergo approval through the New Drug Approval System.
OTC medications can carry risk. There is the possibility of side effects, drug or food interactions, or harm due to excessive doses. Patients should read the ‘Drug Facts’ label that is found on all OTC products. All consumers, including older patients, pregnant women, and parents of young children should always consult with their pharmacist or other health care provider if they have additional questions concerning OTC drug use.