Rx & OTC Medications

FTA Drug and Alcohol Regulation Updates
Issue 23, page 5

Over-the-Counter Medications—Are They Safe?

     Over-the-counter (OTC) medications can be found in nearly every American household. OTCs are medicines the U.S. Food and Drug Administration decides are safe and effective for use without a doctor’s prescription. These non-prescription medications are used to treat a wide-range of illnesses and injuries.

    Many OTCs were initially available by prescription, but have been reclassified as OTCs because the FDA determined these drugs were safe enough to be sold directly to consumers. This does not mean, however, that their use is risk free. In many cases, the dosage strengths and ingredients remained the same as their prescription counterparts. By increasing the accessibility to these medications, individuals are allowed to take a more active role in their health care. However, with this freedom to make important health care decisions comes a greater responsibility to become better informed about self-care.

    To become better informed, you must read and understand the information on OTC labels. The FDA requires all OTCs to have information listed in the same order, arranged in an easy to read, consistent style with easy to understand words. OTC labels provide the following information:

Active Ingredients: The therapeutic substance in the product and the amount of active ingredient per unit. This is the chemical compound in the medicine that works with your body to bring relief to your symptoms. It will always be the first item on the label. If taking more than one medication, be sure to compare the active ingredients to be sure you are not double dosing by getting the same active ingredient in more than one medication.
Purpose: Product action or category (i.e., antihistamine, antacid, cough suppressant.
Uses: Lists only the symptoms or diseases the product will treat or prevent. Sometimes referred to as “indications.” The product should not be used to treat any other symptom or illness unless directed to do so by a physician.
Warnings: This section informs you of when not to use the product or when to stop taking the product. Lists conditions that may require advice from a doctor. Lists possible interactions or side effects. This section will tell you what other medications, foods or situations to avoid (such as driving) when taking this medication. Provides guidance for pregnant or breast-feeding mothers, and cautions for children.
Directions: Provides directions on how much to take, how to take it, how often and how long to take it. The directions may vary by age category. Follow the dosage requirements as recommended on the label. Do not take higher doses or take them for longer periods of time than recommended
Other Information: How to store the OTC will be listed here, as well as information on certain ingredients such as the amount of calcium, potassium, or sodium contained in the product. Any other important information about the product will also be listed here.
Inactive Ingredients: Chemical compounds found in the medicine such as binders, colors, preservatives or flavoring that have no effect on your body.

   Labels also provide the expiration date for the medicine. OTCs should never be used after the expiration date. Most manufacturers also provide a toll-free number to call if you have questions, comments or problems with the medication.

   Be sure to read the label each time you purchase a product. Even though products from the same brand family may look alike, it doesn’t mean they are meant to treat the same conditions or include the same ingredients. Manufacturers or OTC medicines may also make changes to their products or labeling changing ingredients, changing dosages, and/or adding warnings. Likewise, competitors packaging is often designed to look like another brand and are placed on the shelf in close proximity making it easy to mistakenly select the wrong product. OTCs are also often offered in several strengths. Knowing exactly which active ingredients we need, what strength is appropriate (i.e., regular, extra-strength, maximum strength), and the mode of administration (i.e., tablets, capsules, gel caps, liquid) is confusing. Given so many choices, it is difficult to know what to take. If you need assistance, make sure you talk to a doctor, nurse, or pharmacist.

Conforming Products List
Evidential Breath Testing (EBT) Devices July 21, 2000
Federal Register Vol.65 Pages 45419 - 45423
Primary Topic:
Conforming Products List (CPL) Website location: http://www.nhtsa.gov/
people/injury/alcohol
Note: This list will be updated periodically.

Non-evidential Testing Devices
May 4, 2001
Federal Register Vol.66 Pages 22639 - 22640
Primary Topic:
Initial Alcohol Screening Devices

Note: This list will be updated periodically.

The information presented on this page should be used to update Chapter 5 of the Implementation Guidelines.