Over-the-counter medicine (OTC) or nonprescription medicine are medications that people can buy without a prescription. They are safe and effective when you follow the directions on the label and as directed by your health care professional. The most purchased OTC medications include pain relievers like acetaminophen (Tylenol) and ibuprofen (Advil, Motrin), cough suppressants such as dextromethorphan (Robitussin) and antihistamines like loratadine (Claritin 24H). OTC medicines treat symptoms such as pain, coughs and colds, diarrhea, heartburn, constipation, acne, and others. Over-the-counter medicine are found in shelves in pharmacies, grocery stores, and even in gas stations.

Over-the-counter medications can still carry a risk, even though they do not require a prescription. There is the possibility of side effects, drug interactions, or harm due to excessive doses. Consumers should read the “Drug Facts” label that is found on all OTC products. All patients should consult with their doctor, pharmacist or other health care provider if they have additional questions concerning OTC drug use. Pregnant women should speak with their doctor before taking any medication, vitamin, or herbal supplement, even if it’s an OTC product.

Many OTC drugs have undergone a prescription to over-the-counter switch-Rx-to-OTC switch. This means that drugs that were previously available only with a prescription but now can be bought as a nonprescription product. An example include  esomeprazole (Nexium 24HR) and stomach acid blockers like famotidine (Pepcid AC).

The U.S. Food and Drug Administration’s (FDA) Division of Drug Information (CDER), the Office of Drug Evaluation, and the Nonprescription Drug Advisory Committee are organizatios responsible for review of OTC medications. These teams evaluate and review 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 FDA’s New Drug Approval System. Chicago style