Pharmacy and Medications

Over-the-Counter (OTC) Drugs

When pharmacists talk to consumers about a possible side effect from one of their medications, they normally ask a number of questions about the medical history and any other medications the person may be taking, including those purchased over-the-counter (OTC). A frequent response when asked about OTC preparations is, "Oh, that wouldn't cause any problem. It's not the same as a 'drug.' I wouldn't be able to just buy something that might hurt me."

Dangerous Misconceptions About OTCs

Unfortunately, these attitudes are all too common. They form the basis of a number of dangerous misconceptions about OTC medications held by consumers, including the following:

Dangerous Misconceptions About Over-the-Counter Drugs

OTC drugs work differently than prescription drugs.
Medicine sold over-the-counter is completely safe and could not cause any side effects or toxicity.
Reading the whole label is not really necessary. I know why I am taking it.
If the recommended dose does not work, just take more.
I can take the product as long and as often as I 'need' to.
It's only important to talk to your doctor or pharmacist about prescription drugs.

EACH OF THE ABOVE STATEMENTS IS FALSE. If you found yourself agreeing with any of them, read on.

Many of the OTC drugs, also called nonprescription drugs, found in pharmacies today started out as prescription drugs. For the FDA to change a prescription drug to an OTC, it must have a generally good safety profile and be used for a condition or symptoms that can be readily "self-diagnosed." Usually the dose is smaller, but OTCs work the same way in the body and have the potential to cause similar side effects as their prescription versions, especially if not used as directed on the product label. A drug's availability over-the-counter makes it more convenient for the consumer, but it also makes the consumer responsible for its proper use.

Reading the Label

Part of that responsibility is reading the entire label on an OTC product.

Reading the label has often been a difficult task. The print was too small, the words were too big, and it was hard to compare one product to another because the information was usually not in the same place from label to label. However, in 1999 the Food and Drug Administration's division of OTC drug products released new guidelines to help address these problems. Their goal was a simple, standard label format with large print and easy to understand language. Ingredients, uses, warnings and directions would be easy to find on any product. Companies were given five years to make these label changes. Even with the new, easier-to-read labels, consumers should never hesitate to talk to their doctor or pharmacist when choosing an OTC medication.

Think about the following when reading OTC labels:

Trade name
Be sure to pay attention to the whole name. Most companies build on trade name recognition. As many as a dozen different products, each with a different purpose or use, can be marketed with the same basic trade name. Just a minor change such as one or two letters or the word "Free" may be all that is noticeable on a first glance.

For example, Anacin™ contains aspirin as the pain reliever while Anacin Free™ contains acetaminophen; Tylenol™ contains acetaminophen while Tylenol PM™ contains acetaminophen and diphenhydramine, an antihistamine that causes drowsiness. You can end up with an entirely different product if you are not paying attention.

Ingredients
This section is the most difficult. However, it is important that you read and understand the information. It is usually divided into "active" and "inactive" ingredients.

Active ingredients are those that directly affect the symptoms for which you selected the product. For example, pseudoephedrine acts as a decongestant, and it can be used for a stuffy nose. Acetaminophen acts as a pain reliever and lowers fevers. Its uses include relief from aching and fever due to flu.

Many OTC's contain more than one active ingredient as a convenience for the consumer. This convenience of getting "everything" you need in one product can also lead to unintentional overuse and toxicity.

Since many consumers are not just using one product, those who have not familiarized themselves with the entire list of active ingredients may be getting that same ingredient from multiple products, causing an accidental overdose.

The term "inactive" on an OTC label only means that the ingredients do not have a direct effect on what the product is being marketed for. But they should not be ignored because they may be active in other ways. For instance, alcohol is used in some products to help dissolve the other ingredients. While the product is not being used for its alcohol content, the alcohol may cause an adverse effect in some people in terms of interactions with other medications they may be taking or interactions with medical problems or diseases the person may have. Inactive ingredients such as some dyes may cause allergic reactions in sensitive people.

Use(s)
Keep in mind that there can be more than one cause of a symptom you may be experiencing and those causes may be treated very differently. For example, an OTC pain reliever and anti-inflammatory may be appropriate for a simple lower back pain due to overexertion. However, if the backache is caused by a kidney infection, an antibiotic may be needed.

Warnings
This section tells the user about potential problems that the medication can cause. Warnings can include side effects, interactions with other medications (both prescription and OTC), interactions with disease states, interactions with foods, as well as cautions about use during pregnancy, in certain age groups, and if you must perform certain activities. This section will often instruct you not to exceed the maximum recommended dose and duration of use. Paying attention to these warnings can help you avoid preventable adverse reactions. Read the Warnings BEFORE you take the medication. Too many people find themselves in their doctor's office or an emergency room due to an adverse reaction because they didn't read the label first.

Directions
This section explains how much to take and how often to use a product. Just as importantly, it tells you when to stop! This is done by stating the total number of doses allowed per day as well as maximum number of days that the product should be used without consulting your doctor. Taking more than recommended dose only increases the probability of side effects or other adverse reactions. In some cases, it can also actually make the problem worse due to what is called a "rebound effect," where the problem comes back even worse than before. If the recommended dosage does not provide the intended action, it is likely that a different medication and a doctor's evaluation are needed. Remember that you have made a self-diagnosis. You may be delaying proper treatment if the problem is not what you think it is.

OTC products play a big role in today's healthcare choices. Consumers are able to self-medicate many problems. However, with the convenience also comes the responsibility to use the drug properly and safely. The valuable information provided on the product label must be read and understood. Even with the new, simplified label wording and format, your pharmacist or physician is there to help clarify the information and answer questions. Do not hesitate to ask for their assistance.

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Last Reviewed: May 11, 2007

Gaylene B Tsipis, MS, RPh
Adjunct Assistant Professor of Pharmacy Practice
College of Medicine
University of Cincinnati