Medicine container and carton labels, the way it is packaged, and its name or names should communicate information that is critical to the safe use of the medicine. However, a report from the Institute of Medicine in 2006 cited medicine labeling and packaging issues as the primary cause of 33% of all medication errors and 30% of deaths from medication errors.1 Key information may be missing, poorly visible, or hard to understand on labels. Different medicine labels or names may look alike, or marketing information on medicine labels may be misleading to consumers. The packages medicines come in may confuse consumers, or the label may be so cluttered that information is difficult to find. Click on the pages below to learn more about how labels, packages, and names can cause confusion to be sure you don't make these mistakes.
1) Institute of Medicine of the National Academies. Preventing Medication Errors. Aspden P, Wolcott JA, Bootman L, Cronenwett LR, eds. 2006; Washington, DC: National Academies Press.
Because there are so many different products on the market to treat the same symptoms, a drug company may entice consumers to purchase its product by using attention-catching adjectives on the label. The Tylenol cold and flu medicine to the right, for example, uses prominently placed terms such as “Warming,” SEVERE,” and “HONEY LEMON” to draw attention to attributes of a medicine that might appeal to a consumer suffering from a cold and flu. The problem is, you might get sidetracked by the appealing terms on the label and overlook the actual active ingredients and dose. The active ingredients are often found on the front label, but, as in this case, the eye-catching adjectives are much more prominent on the label. It is important to focus on the active ingredients, purpose, and dose of the product, which can be found on the Drug Facts label.
The same drug may come in several different forms and in more than one dose. Yet, many drug manufacturers package these products in containers that look alike, making it difficult to notice the differences. For example, the two boxes of Claritin (loratadine) allergy medicine below look nearly identical. Both are Claritin RediTabs. But, the package on the left contains 5 mg of loratadine and is released over 12 hours, and the package to the right contains 10 mg of loratadine and is released over 24 hours. To be sure you have the correct product in hand, read the front label and the Drug Facts label to identify the active ingredients and the amount of drug in each dosage unit (e.g., pill, tablet, capsule, volume of liquid medicine).
Same brand name for different products
Companies will often use a well-known, trusted brand name for one product to launch an entire line of products, even if products are completely different. You can find examples of this by strolling down the aisles of your grocery store. For instance, JELL-O is a common brand name that is well known for gelatin desserts. However, there are also non-gelatin products such as pudding and pie filling that are sold under the JELL-O brand. Drug companies will also capitalize on a well-known, trusted brand name to introduce a new product that may contain an active ingredient that is not in the original product. In fact, sometimes the new product does not have any of the active ingredients in the original product—it’s a totally different product, perhaps used for a totally different condition. This is known as “brand name extension.” These products have been associated with medication errors in which the wrong product or dose was taken. In one such case, a man whose doctor prescribed Dulcolax tablets to help clear his bowels before a colonoscopy took another “Dulcolax” product by accident. The bottle of “Dulcolax” he purchased contained the stool softener docusate (picture on left), not the strong laxative bisacodyl (picture on right) his doctor wanted him to take. The colonoscopy could not be completed. To be sure you have the correct brand-name product, always read the Drug Facts label to identify the active ingredients, purpose, and dose.
How a product is packaged can contribute to confusion regarding its use. For example, numerous events have been reported in which a small tube of Super Glue (photo 1) was mistaken as an eye ointment and placed in the eye by accident.
Benadryl (diphenhydramine) Itch Stopping Gel is another example (photo 2). Benadryl is an antihistamine that has been on the market for many years. The Benadryl line of products has grown over the years, and it now includes many combination products to treat various symptoms. These products are widely available as a topical cream, oral liquid, capsule, tablet, spray, topical gel, topical itch relief stick, and an injectable product. Benadryl Gel is available in a 4 ounce bottle. The clear gel has a consistency more like liquid than a gel. It can easily be mistaken as an oral liquid, particularly since the bottle has the same shape and size as other oral liquid products. In 2010, the US Food and Drug Administration (FDA) warned consumers not to swallow Benadryl Itch Stopping Gel—it is only supposed to be applied on the skin. Between 2001 and 2009, 121 cases of ingestion of this product were reported to the manufacturer, Johnson and Johnson. Of these cases, 7 were serious and required treatment in the emergency room, hospitalization, or admission to the intensive care unit. Others reported adverse events included hallucinations, unconsciousness, sleepiness, difficulty walking, dizziness and inability to speak. Since 2010, the manufacturer of Benadryl Itch Stopping Gel have revised their labeling and added the warning statement: For Skin Use Only.
Another example that might be dangerous to children involves medicine packaged much like breath mints or breath freshener strips. Nicorette mini Lozenges, which look much like Tic Tacs, come in a small shake-out container just like the breath mints, and Unisom sells an orally dissolving film strip that looks just like breath freshener strips. The Unisom product, which contains melatonin, is packaged just like the breath freshener strips in a small container that allows the removal of one strip at a time. Melatonin is a hormone produced aby the body that’s involved in the management of sleep and wake cycles. These products are flavored and may be attractive to children. A mother reported that a child at her son’s school recently shared what he thought were breath freshener strips with several children before it was recognized that the product was the Unisom Nighttime Strips. These children were not harmed, but a group of young children were taken to a hospital this year after they ate what they thought were breath mints but were actually the Nicorette mini Lozenges.
Hidden Drug Facts labels
Because the containers that hold some OTC medicines are small, manufacturers provide important safety information, including the Drug Facts label, underneath the main label. To view the label, a section of the main label must be peeled back. On these containers, the words “Peel here” or “Peel back for Drug Facts” is located in the top or bottom corner of the outside label. Some individuals may not notice that they must peel back the label, and in doing so may miss important information. Others may think they aren’t supposed to peel back the label without first purchasing the product. However, these labels are mostly designed to re-stick to the bottle after being peeled back. So take the time to read the Drug Facts label before purchasing a product to be sure it is right for you.
Strengths that differ among oral dosage forms (e.g., tablets, capsules, gel capsules, melting tabs, enteric coated tablets, chewable tablets) Drug companies often sell various dosage forms of a single, oral product to appeal to personal preferences and to make it easier to swallow a medicine. For example, OTC adult-strength ibuprofen comes in various types of tablets and capsules, but all of the capsules and tablets each contain 200 mg of the drug.
Only the children’s suspension and children’s chewable tablets come in lower strengths. So, a consumer might assume that all adult tablets or capsules for a particular OTC medicine come in the same strength.
While this might be true for many oral products, it is not true for all. For example, the sleep aid Unisom (diphenhydramine) comes in various oral dosage forms including gel capsules (called SleepGels) and melt-in-your-mouth tablets. However, the SleepGels contain 50 mg of diphenhydramine, and just one capsule is taken per dose; whereas, the SleepMelts contain 25 mg of diphenhydramine, and two tablets are required for a single dose. If switching from SleepMelts to SleepGels, someone might mistakenly believe that the usual dose is “two” capsules, just as it was for the SleepMelts. This would result in an overdose. If switching from the SleepGels to the SleepMelts, only one tablet might be taken, which is only half of the recommended dose. Even when simply changing from one oral dosage form to another—capsules to tablets, for example—always verify how many to take with each dose by reading the Drug Facts label.
Strengths that differ among oral dosage forms (e.g., tablets, capsules, gel capsules, melting tabs, enteric coated tablets, chewable tablets)
Drug companies often sell various dosage forms of a single, oral product to appeal to personal preferences and to make it easier to swallow a medicine. For example, OTC adult-strength ibuprofen comes in various types of tablets and capsules, but all of the capsules and tablets each contain 200 mg of the drug. Only the children's suspension and children's chewable tablets come in lower strengths. So, a consumer might assume that all adult tablets or capsules for a particular OTC medicine come in the same strength. While this might be true for many oral products, it is not true for all. For example, the sleep aid Unisom (diphenhydramine) comes in various oral dosage forms including gel capsules (called SleepGels) and melt-in-your-mouth tablets. However, the SleepGels contain 50 mg of diphenhydramine, and just one capsule is taken per dose; whereas, the SleepMelts contain 25 mg of diphenhydramine, and two tablets are required for a single dose. If switching from SleepMelts to SleepGels, someone might mistakenly believe that the usual dose is "two" capsules, just as it was for the SleepMelts. This would result in an overdose. If switching from the SleepGels to the SleepMelts, only one tablet might be taken, which is only half of the recommended dose. Even when simply changing from one oral dosage form to another—capsules to tablets, for example—always verify how many to take with each dose by reading the Drug Facts label.
Lack of highly visible warnings
Since 2010, we have been warning consumers who wear contact lenses about Clear Care, a lens cleaning product containing 3% hydrogen peroxide. This product, and similar generic brands, must only be used with a special lens case (Figure 1) with a built-in neutralizer—a platinum-coated ring that turns hydrogen peroxide into water after about 6 hours. Only after this process can the lenses be placed safely back into the eyes. The product label cautions consumers to use only the lens case provided and to not rinse lenses with Clear Care prior to insertion. But many consumers do not notice the warning, especially without their lenses. Some mistakenly think, "Why use the special lens case when I have my own case?" Also, those who do not routinely rinse their lenses (with saline) may ignore the warning, thinking it doesn't apply to them. Thus, hundreds of consumers have used the product improperly, causing severe eye injuries.
In a recent case reported in 2014, a young woman used Clear Care for the first time after running out of her usual solution. She found the product on the pharmacy shelf right next to other lens cleaning solutions. The label had a picture of a contact lens on it, and the bottle resembled those used for other contact lens solutions. She was not aware that the product contained hydrogen peroxide. She could not see well without her contact lenses in place, so she failed to notice what she later described as the "meager" cautionary message on the label stating that the special lens case must be used. She rinsed her contact lenses with Clear Care and put them in her eyes. As a result, she experienced excruciating pain and burning, which progressed to a swollen and reddened eye despite flushing with natural tears. Still in pain after several hours, and afraid there was serious damage to her eye, she needed to visit an eye doctor.
When purchasing lens care products, to make sure you have the correct product. If you use Clear Care, or another similar generic product, read the instructions carefully, use the special case provided for soaking your lenses, and make sure the lenses have been soaking for at least 6 hours. Talk to your pharmacist if you have any questions.
Hidden ingredients that may cause problems
OTC products may contain ingredients to which people are allergic. However, it might be hard to determine whether products contain potential allergens if they are listed on the Drug Facts label in the Inactive Ingredients section, rather than in the Active Ingredients section. Soy, gluten, and peanut oil are prime examples. These potential allergens may be hidden in the Inactive Ingredients section and overlooked. Or, the potential allergen might be an Active Ingredient but not easily recognized as such. Take people who are allergic to aspirin or a non-steroidal anti-inflammatory drug (NSAID), and a common OTC product, Kaopectate, which is used to treat diarrhea, indigestion, heartburn, and nausea. The Active Ingredient in Kaopectate is bismuth subsalicylate. Bismuth subsalicylate should not be taken by anyone who is allergic to aspirin or an NSAID because it is an aspirin-like substance. An Allergy Alert that warns consumers not to take Kaopectate if they are allergic to aspirin can be found under the Warnings section of the Drug Facts label.