Over the Counter Medications
Medically reviewed on Mar 26, 2018 by L. Anderson, PharmD.
In the U.S., there are more than 80 classes of over-the-counter (OTC) medications, ranging from acne medicines to weight loss products.
OTC drugs are medications that are safe and effective for use by the general public without seeking treatment by a health professional. Popular examples include pain relievers like acetaminophen (Tylenol) and ibuprofen (Advil, Motrin), cough suppressants such as dextromethorphan (Robitussin) and antihistamines like loratadine (Claritin 24H). These drugs are usually located on shelves in pharmacies, grocery stores, and even in gas stations. OTC medicines treat a variety symptoms due to illness including pain, coughs and colds, diarrhea, heartburn, constipation, acne, and others.
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More information about OTC products
What is an Rx-to-OTC switch?
Many OTC drugs have undergone a prescription to over-the-counter switch -- also known as “Rx-to-OTC switch” -- meaning they were previously available only with a prescription but now can be bought as a nonprescription product. For example, proton-pump inhibitors like esomeprazole (Nexium 24HR) and stomach acid blockers like ranitidine (Zantac 150), both used for heartburn, are examples of products that have made the Rx-to-OTC switch. The emergency contraceptive pill (“the morning-after pill”) known as Plan B One Step is now available OTC without age restriction and can be found on the shelves in many pharmacies in the U.S.
Are some drugs kept behind the pharmacy counter?
A more restricted class of OTC drugs also exists. These products, while considered OTC, are kept behind the pharmacy counter and are dispensed by a pharmacist. Some products, such as pseudoephedrine (Sudafed), which is subject to abuse, may require proper identification and a signature. Naloxone is a life-saving drug that can reverse sedation and depressed breathing in an opioid-overdose. In many states, pharmacists are now allowed to dispense naloxone (Narcan Nasal, Narcan) to the public based on a standing prescription order or other rules specific to their state.
Does the FDA review over-the-counter (OTC) drugs?
The review of OTC medications is primarily handled by 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. 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.
Are over-the-counter (OTC) drugs safe to use?
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.