Consumer Health Information Corporation: Be Prepared

Know Your "Drug Facts" Before You Self-Treat

Janel R. Mann
Doctor of Pharmacy Candidate 2002
University of Iowa

Many Americans turn to over-the-counter medicines to self-treat their common health problems. About 5 billion over-the-counter (OTC) medicines are bought and used each year to treat common health problems. When was the last time you purchased an over-the-counter medicine? Did you have a hard time deciding which product to buy? With thousands of over-the-counter products available to help you relieve your symptoms, choosing one that is right for you may be difficult. future terrorist attacks.

In 1999, the U.S. Food and Drug Administration (FDA) required all over-the-counter product labels to provide certain information and make it easier for people to understand how to compare and select over-the-counter medicines. The new label is called "Drug Facts". By 2005, all OTC products should have the new labeling.

Even with a new "easy to read" label, you still need to decide if a product is safe for you to use. Not every over-the-counter medicine may be right for you. Everyone is different, so you should select OTC medicines carefully. A wise purchase can help you and be very cost-effective, but an unwise purchase could cause medical problems and cost you money on doctor's visits.

Ask yourself the following questions before you decide to buy your next over-the-counter medicine. Using the "Drug Facts" on the new label will also help you to answer these questions.

What type of medicine is it?
To answer this question you need to look at the "Active Ingredient" section listed on the new label along with the "Purpose" section. The "active ingredient" is the specific medicine in the product that makes it work. The purpose describes the types of symptoms the medicine relieves. For example:

In Tylenol®, the active medicine is "acetaminophen". Acetaminophen's purpose is written as a "pain reliever/fever reducer".
For an allergy medicine, such as Benadryl®, the active substance is "diphenhydramine" and the purpose given is an "antihistamine".
If the OTC product contains more than one active ingredient, there will be more than one active ingredient listed and a purpose for each.

Will this help relieve my symptoms?
Look on the label for "Uses". This will tell you what you should use the medicine for. For example:

An allergy medicine, such as Benadryl®, states "temporarily relieves the symptoms due to hayfever or other upper respiratory allergies." It also lists symptoms (sneezing, runny nose, and itchy/watery eyes) for which the medicine can be used.

Am I allergic to any of the ingredients in this product?
This should be one of the first questions that you ask yourself, especially if you have many allergies. You should check both the "Active Ingredients" and "Inactive Ingredients". Examples of inactive ingredients are dyes and flavorings. Dyes can be used to color tablets making them look different from one another. Flavorings are added to improve taste. Many consumers forget to look at the inactive ingredients, which can sometimes be the cause of an allergic reaction. Some products may have an "Allergy Alert" that lists the more common allergic reactions in the "Warnings" part of the label. For example:

Motrin IB (ibuprofen), a common pain reliever, has an "Allergy Alert" that states "ibuprofen may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing),or shock."

Make sure you know the signs of an allergic reaction so that you can get help right away.

Is this product safe for me to use?
For this question, look at the "Warnings" on the label. This part of the label contains a lot of important information so read it carefully. It may start out with "Do not use" and then lists when the product should not be used under any circumstances. For example:

Many laxatives, such as Ex-Lax®, have the statement "Do not use for a period longer than 1 week."

It is important that you stop taking the medicine and talk to your doctor if you've had little or no relief within a week. Laxatives were not designed to be used longer than one week. Using a laxative longer than a week could lead to other more serious problems that may require your doctor's attention. Remember, OTC products only relieve symptoms. They do not cure diseases.

Do I have any medical conditions that make it unsafe for me to use this product?
Under "Warnings", you will want to look for "Ask a doctor before use if you have." This section is different depending on the actual product but includes warnings for persons with health problems such as high blood pressure, heart disease, glaucoma, asthma, or diabetes. It also includes warnings for persons that are having certain symptoms. This section explains when you should consult your health care provider before taking the medicine. For example:

An antacid that contains aluminum, such as Maalox® liquid, states "Ask a doctor before use if you have kidney disease."

If your kidneys are not working right, aluminum could build up in your body over time. Too much aluminum in the body could cause constipation and could weaken your bones. Your doctor can tell you how well your kidneys are working and if you can use antacids containing aluminum.

Am I taking any other medicine(s) that shouldn't be taken with this product?
Under "Warnings", look for the section with "Ask a doctor or pharmacist before use if you are." Here you will find a list of medicines that can interact with the OTC product. Foods or beverages to avoid while taking the medicine may also be listed.
For example:

Bayer® aspirin, a common pain reliever, states that you should "Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning the blood), diabetes, gout, or arthritis."

Make sure you tell your doctor or pharmacist about all the medicines you take, both prescription and over-the-counter, including any dietary supplements or herbal products. Your doctor and pharmacist need this information to make sure your medicines are safe to take at the same time.

Does this product commonly cause any side effects that I am not willing to risk?
This is also included in the "Warnings" on the label under "When using this product". The most common side effects are listed on the label. For most people, over-the-counter medicines are safe and effective when used for short periods of time to help relieve minor symptoms. But for some people over-the-counter medicines can cause side effects. Most side effects are minor. However, if your side effects are severe or continue, you should stop taking the medicine and call your doctor or pharmacist.

The label may also include "Stop use and ask a doctor if". This section, depending on the product, may explain any serious side effects that require an immediate call to your doctor. For example:

The label for Motrin® IB (Ibuprofen) states the warning, "Stop use and ask a doctor if:

an allergic reaction occurs. Seek medical help right away.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
stomach pain or upset gets worse or lasts
redness or swelling is present in the painful area
any new symptoms appear"

This information is important to know so you can catch problems early and seek medical help.

The "When using this product" section, if necessary, will describe things to avoid while taking the medicine. One common warning found on many OTC labels is "Do not drink alcoholic beverages while taking this medicine." This is because with certain medicines, mixing alcohol can cause serious problems. For example:

Drinking alcohol while taking certain OTC cough, cold, or allergy medicines can make you sleepy and cause you to feel confused.
Drinking alcohol while taking certain OTC medicines can also make it dangerous to drive a car or operate machinery.
Drinking alcohol when taking aspirin can cause irritation to your stomach.

Will I be able to take this medicine according to the directions considering my daily activities?
The "Directions" section on the label is where you will find how much of the medicine to take, when, how, and how often to take it. If you don't think that you will be able to take the medicine exactly as directed, then you may want to look for another product. For example:

If you have trouble swallowing a large pill, you may want to look for the same medicine in a liquid form.
Your schedule may not allow you to take the medicine as often as needed, so you may want to look for a medicine that can be taken less often.
It is important to follow the directions and not use the medicine for longer than the time listed on the label.

The label will tell you when to talk to your doctor if your symptoms have not been relieved.

What "Other Information" do I need to know?
The section called "Other Information" will state how to store your medicine. It includes information such as "protect from excessive moisture" and "store at 20-25°C (68-77°F)" (which is room temperature).

This section may also give you important information about certain ingredients. The amount of sodium is listed in this section if the amount in a single dose of the product is greater than 5 milligrams (mg). This is helpful information for certain people, such as those with high blood pressure that have been told to watch the amount of sodium in their diet. If the amount of sodium in the product is high, a special warning is placed in the "Warnings" section of the label. It states "Do not use this product if you are on a sodium-restricted diet unless directed by a doctor."

Another important statement sometimes found in this section is a reminder to save the box/container for important information. Many times there is no additional information inside the box of over-the-counter medicines and the product's label can be too small to contain all the information that you need. It is important to keep the box with the product so you will always have the information you need to use the medication safely.

The new "Drug Facts" labeling is going to start appearing on every OTC product within the next few years. The new label can help you decide if an over-the-counter product is right for you. Make sure to read the whole label each time you buy medicine. This is important because the labels on medicines may change as new information becomes available.

If you still have questions after reading the label or feel you need some help in selecting the best product for your symptoms, ask your pharmacist for help. Pharmacists have the knowledge and resources to help you decide what medicine is right for you. The most important thing to remember is to ask for help if you have any questions and know all the "Drug Facts" before you decide to self-treat with an OTC medicine.



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