Over-the-counter (OTC) medications are those available without a prescription.
Topic Resources
OTC medications help people relieve many symptoms and to cure some simple diseases easily and without seeing a doctor. However, safe and effective use of these medications requires knowledge, common sense, and responsibility.
In addition to medications such as aspirin and acetaminophen that people typically think of as OTC, in the United States many other commonly available products are considered OTC medications by the Food and Drug Administration (FDA). Some toothpastes, some mouthwashes, some types of eye drops, wart removers, first aid creams and ointments that contain antibiotics, and even dandruff shampoos are considered OTC medications. Which products are available OTC is determined by each individual country. In addition to medications such as aspirin and acetaminophen that people typically think of as OTC, in the United States many other commonly available products are considered OTC medications by the Food and Drug Administration (FDA). Some toothpastes, some mouthwashes, some types of eye drops, wart removers, first aid creams and ointments that contain antibiotics, and even dandruff shampoos are considered OTC medications. Which products are available OTC is determined by each individual country.
Some OTC products were originally available only by prescription. After many years of use under prescription regulation, medications with excellent safety records may be approved in the United States by the FDA for over-the-counter sale. The analgesic ibuprofen and the heartburn remedy famotidine are examples of such medications. Often, the OTC version has a lower amount of active ingredient in each dose of medication than does the prescription version of the same medication. When establishing appropriate doses of OTC medications, manufacturers and regulatory authorities responsible for overseeing medications, like the FDA in the United States, try to balance Some OTC products were originally available only by prescription. After many years of use under prescription regulation, medications with excellent safety records may be approved in the United States by the FDA for over-the-counter sale. The analgesic ibuprofen and the heartburn remedy famotidine are examples of such medications. Often, the OTC version has a lower amount of active ingredient in each dose of medication than does the prescription version of the same medication. When establishing appropriate doses of OTC medications, manufacturers and regulatory authorities responsible for overseeing medications, like the FDA in the United States, try to balancesafety and effectiveness.
OTC medications are not necessarily better tolerated than similar prescription medications. For example, the OTC sleep aid diphenhydramine can cause adverse effects that are just as serious as those associated with many prescription sleep aids, especially in older adults.OTC medications are not necessarily better tolerated than similar prescription medications. For example, the OTC sleep aid diphenhydramine can cause adverse effects that are just as serious as those associated with many prescription sleep aids, especially in older adults.
History of Medication Regulation in the United States
At one time, most medications were available without a prescription in the United States. Before the Food and Drug Administration (FDA) existed, just about anything could be put in a bottle and sold as a sure-fire cure. Alcohol, cocaine, marijuana, and opium were included in some over-the-counter (OTC) products without notification to users. The Food, Drug, and Cosmetic (FD&C) Act of 1938, gave the FDA some authority to issue regulations, but the act did not provide clear guidelines as to which medications could be sold by prescription only and which could be sold over the counter.At one time, most medications were available without a prescription in the United States. Before the Food and Drug Administration (FDA) existed, just about anything could be put in a bottle and sold as a sure-fire cure. Alcohol, cocaine, marijuana, and opium were included in some over-the-counter (OTC) products without notification to users. The Food, Drug, and Cosmetic (FD&C) Act of 1938, gave the FDA some authority to issue regulations, but the act did not provide clear guidelines as to which medications could be sold by prescription only and which could be sold over the counter.
An amendment to the FD&C Act in 1951 attempted to clarify the difference between OTC and prescription medications and to address safety issues. Prescription medications were defined as compounds that could be habit forming, toxic, or unsafe for use except under a doctor's supervision. Anything else could be sold over the counter.
As noted by an amendment to the FD&C Act in 1962, OTC medications were required to be both effective and safe. However, determining effectiveness and safety can be difficult. What is effective for one person may not be for another, and any medication may cause unwanted side effects (also called adverse effects, adverse events, or adverse drug reactions). There was no organized system in the United States for reporting the adverse effects of OTC medications until 2007, when a new law became effective that required companies to report serious adverse events associated with OTC medications (see OTC Products and Dietary Supplements).
Safety Considerations
Safety is a major concern when the Food and Drug Administration (FDA) considers reclassifying a prescription medication as OTC (over-the-counter). Most OTC medications—unlike health foods, dietary supplements (including medicinal herbs) and complementary therapies—have been studied extensively. However, all medications have benefits and risks, and some degree of risk must be tolerated if people are to receive a medications benefits. Defining an acceptable degree of risk is a judgment call.
Reclassifying prescription medications as over-the-counter medications
The following questions can help regulatory authorities determine whether a medication is safe enough to be made available over the counter:
Has the medication been used for a long enough time so that any harmful effects are fully understood?
What harmful effects (including those from misuse) may the medication cause?
Is the medication habit forming?
Do the benefits of over-the-counter status outweigh the risks?
Other questions help determine the ease with which a disorder can be diagnosed and then treated outside of a health care setting:
Can the average person self-diagnose the condition that calls for the medication?
Can the average person treat the condition without the help of a doctor or other health care professional?
Finally, people need to understand how to use the medication, so labeling on the outside and inside of the package are important considerations. The following questions help determine what information is included in the medication's labeling:
Can adequate directions for use be written?
Can warnings against unsafe use be written?
Can the average person understand the information on the label?
Choosing and using over-the-counter medications
Safety depends on using a medication properly. For OTC medications, proper use often relies on consumer self-diagnosis, which leaves room for error. For example, most headaches are not dangerous, but in rare cases, a headache is an early warning of a brain tumor or hemorrhage. Similarly, what seems like severe heartburn may signal an oncoming heart attack. Ultimately, people must use common sense to determine whether a symptom or ailment is minor or whether it requires medical attention and consult a doctor or pharmacist if they are unsure.
Some guidelines for choosing and using OTC medications are as follows:
Make sure that the self-diagnosis is as accurate as possible. Do not assume the problem is “something that is going around.”
Choose a product because the ingredients are appropriate for the condition, not because the product has a familiar brand name.
Choose a product with the fewest ingredients. Products that claim to relieve every possible symptom are likely to expose people to unnecessary medications, pose additional risks, and cost more.
Read the label carefully to determine the correct dose and take note of any precautions, including which medical conditions would make the medication a poor choice.
When in doubt, ask a pharmacist or doctor what the most appropriate product is to treat your symptoms.
Ask a pharmacist to check for potential interactions with other medications the person is using.
Ask a pharmacist to identify possible side effects.
Do not take more than the recommended dose.
Do not take an over-the-counter medication longer than the maximum time suggested on the label. Stop taking the medication and call your health care professional if your symptoms worsen.
Keep all medications, including over-the-counter medications, out of the reach of children.
Reading the labels of over-the-counter medications
People who purchase OTC medications should read and follow the instructions carefully. Because different formulations of the same medication—such as immediate-release and controlled-release (slow-release) formulations—may have the same brand name but different dosage instructions, the label should be checked each time a product is purchased, and the dosage should be noted. Assuming that the dosage is the same between purchases is not safe.
Also, different formulations with the same brand name may have different ingredients, so checking the ingredients on the label is important. For example, there are several dozen different Tylenol® formulations with a vast array of ingredients and doses and some Maalox® products contain aluminum and magnesium hydroxide, while others contain calcium carbonate. Also, different formulations with the same brand name may have different ingredients, so checking the ingredients on the label is important. For example, there are several dozen different Tylenol® formulations with a vast array of ingredients and doses and some Maalox® products contain aluminum and magnesium hydroxide, while others contain calcium carbonate.
When selecting a product, people should read the label carefully to determine which product is most appropriate for their particular problem. Labels on OTC medications, which are required by the FDA in the United States, can help people understand a medication's benefits and risks as well as how to use the medication correctly. People should ask a pharmacist if they have any questions about an OTC product or do not fully understand the directions on the label.
Often, the labels of OTC medications do not list the full range of possible side effects. As a result, many people assume that these medications have few, if any, side effects. For example, the package insert for one OTC pain reliever cautions people not to take the medication for more than 10 days. However, the possible serious side effects that can occur with long-term use (such as life-threatening bleeding from the digestive tract) are not mentioned—not on the box, bottle, or package insert. Consequently, people with chronic pain or inflammation may take the medication for a long time without realizing that such use could lead to serious problems.
Reading a Medication Label
Nonprescription medications in the United States are required to have labels that explain their benefits and risks and how to use the medication correctly. The label is entitled “Drug Facts.” Active ingredients are listed at the top, followed by uses, warnings, directions, other information, and inactive ingredients. Active ingredient: The medication itself is the active ingredient. Combination products have more than one active ingredient. The medication’s generic name is listed with the amount of medication in each tablet, capsule, or dose unit. The same generic medication may be sold under several different trade (brand) names. Uses: Symptoms or disorders for which the medication product is recommended are listed. Warnings: When the medication should not be used, when a doctor or pharmacist should be consulted (and after how long), and which factors can alter the expected response to the medication are listed, usually in the following sections.
Directions: How much of the medication to take and how often to take the medication are given for different age groups, because size and age, among other factors, affect how a person responds to a medication. Other information: Special instructions, such as how to store the medication so that it does not deteriorate, are listed. Inactive ingredients: In addition to the medication, medication products contain substances added to facilitate the administration of the medication, such as ingredients that provide bulk or a pleasant taste and color. Different products with the same active ingredient may contain different inactive ingredients. Inactive ingredients are usually harmless, but some of them cause an allergic reaction in a few people, who should look for products made without those ingredients. |
More Information
The following is an English-language resource that may be useful. Please note that The Manual is not responsible for the content of this resource.
OTC Products and Dietary Supplements: A site for reporting adverse events associated with use of over-the-counter (OTC) medications and dietary supplements.
