Over-the-counter (OTC) drugs can be purchased just as easily as a bottle of shampoo or a box of cereal—but that doesn't mean that they are harmless.
Few people realize that in some cases, OTC drugs contain the same amount of an active ingredient as that found in prescription medications. Using OTC drugs incorrectly—for example, taking them for too long or in excessive doses—can cause serious side effects.
Example 1: People with arthritis often treat their symptoms with OTC painkillers, such as ibuprofen (Advil) or naproxen (Aleve), for months or years—even though the label advises against taking these drugs for more than 10 consecutive days without consulting your doctor.
The long-term use of such drugs greatly increases the risk for stomach bleeding as well as heart and/or kidney problems.
Example 2: If you have hypertension or heart disease, taking a cold remedy that contains pseudoephedrine, such as Sudafed, can cause a life-threatening problem such as atrial fibrillation (a heart-rhythm irregularity) or heart attack.
All OTC medications include a standardized "Drug Facts" label (on the outside of the packaging and also in an insert) that details the approved uses of the drug...active ingredients...how to use it...and possible risks. Even though OTC drug labels were simplified in 2002, the information is often confusing and printed in such small type that it's almost impossible to read.
Note: The FDA recently has required drug manufacturers to redesign prescription drug labels so that they are easier to read.
Important: Bring your reading glasses or a small magnifying glass with you and read the OTC drug label before leaving the store. If you're purchasing from a drugstore, ask a pharmacist to explain any instructions that you don't understand.
What to look for...
ACTIVE INGREDIENT
This term refers to the medication that relieves symptoms. There might be dozens of drugs in a pharmacy that have the same active ingredient.
Example: Advil Cold & Sinus Liqui-Gels and Motrin Cold & Sinus caplets both contain 200 mg of ibuprofen and 30 mg of pseudoephedrine. Knowing the active ingredient makes it easy to comparison-shop for the best price.
What you may not know: Manufacturers occasionally change the active ingredients in OTC products.
Example: The antidiarrheal drug Kaopectate once contained a type of clay called attapulgite.It was safe for patients who were taking blood-thinning medication. Kaopectate now contains bismuth subsalicylate, an aspirin-like ingredient that increases the risk for bleeding in patients taking blood thinners.
INACTIVE INGREDIENTS
This term refers to the chemicals that are used as preservatives, binders and colorants/ flavors—but have no medical effects.
What you may not know: Some people are allergic to certain inactive (as well as active) ingredients.
Example 1: Hundreds of products, such as the OTC antihistamine loratadine (Alavert) and the OTC pain reliever Arthritis Strength BC Powder, contain the inactive ingredient lactose, a milk sugar that can trigger reactions in patients who are lactose intolerant.
Example 2: Gluten, a protein found in wheat, barley and rye, should be avoided by people with celiac disease, but starch, maltodextrin and other substances that could contain gluten are common inactive ingredients in both OTC and prescription medications, such as the OTC anti-gas drug Gas-X Regular Strength Chewable Tablets and the fiber supplement Senokot Wheat Bran.
USES
Known as "indications” on some labels, this term refers to the list of symptoms that a drug is designed to treat.
The FDA allows drug manufacturers to list only uses for which the medication has been proven to be safe and effective.
Example: The label on an antihistamine such as diphenhydramine (Benadryl) says the drug treats sneezing, runny nose and other allergy symptoms.
What you may not know: It can be risky to take drugs "off-label"-that is, taking a medication for uses other than the indications and/or directions found on the label.
Example: Taking high doses of the OTC B-vitamin niacin to lower cholesterol is an off label use. Prescription niacin is approved for lowering cholesterol, but taking it without being monitored by your doctor can lead to liver damage.
WARNINGS
Many patients ignore the warnings on OTC medications because they assume the drugs must be safe or they wouldn't be sold without a prescription. Not true.
OTC drugs can cause side effects that are just as serious as those caused by prescription drugs. Aspirin and related drugs, for example, cause more than 100,000 hospitalizations annually in the US.
What you may not know: In addition to explaining the main risks of a medication, "warnings" may include information on who should not take the medication, when to consult your doctor if symptoms persist, when to take medications with foods (or when to avoid certain foods and beverages), whether it's safe to drive, etc.
Even if you've taken a particular OTC drug for years, check the warning label each time you purchase the medication. A drug that was safe when you first started taking it might cause problems if you've begun taking other medications or if the ingredients or your health needs have changed. Always check the expiration date.
FORMS AND FORMULATIONS
The label on an OTC drug lists the medication's form—tablet, capsule, caplet, etc. The form can affect how quickly the product works... what side effects occur...and how easy it is to take.
Examples…
- Buffered analgesics (pain relievers) are made slightly alkaline to protect the stomach. Patients who experience stomach irritation, pain or heartburn from aspirin or similar drugs might do better with a buffered product.
- Caplets are ordinary tablets in the shape of a capsule. They're easier to swallow than traditional tablets-an important point for patients who have trouble swallowing. Gelcaps, geltabs and capsules are coated with gelatin, making them also easier to swallow.
- Timed-release capsules or tablets. These drugs are designed with various types and layers of coatings around the active ingredients, which allows the medication to be released slowly, resulting in extended drug action.
An enteric-coated drug is treated so that it passes through the stomach unaltered and dissolves in the intestines. Enteric-coated medications take longer to work, so if you have a headache (and do not have a sensitive stomach), it may be better to take regular aspirin than enteric-coated aspirin.
- Extra-strength drugs contain a higher dose of the active ingredient. These medications, such as Extra Strength Tylenol, are helpful if the regular dose isn't adequate to control symptoms—and more convenient than taking two or more doses of a lower-dose product.
- PM (or night formulas), including some antihistamines or pain relievers, such as Excedrin PM, can cause drowsiness, so they're meant to be taken at night.
- Suspension formulas are liquid medications in which the active ingredient isn't dissolved. They require shaking before use (and typically indicate this on the label). Example: The laxative Phillips Milk of Magnesia is an oral suspension medication.
