Over-the-Counter Medicines: What's Right for You?
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Advice for Americans about Self-Care:
Access + Knowledge = Power
American medicine cabinets contain a growing choice of nonprescription,
over-the-counter (OTC) medicines to treat an expanding range of ailments. OTC medicines
often do more than relieve aches, pains and itches. Some can prevent diseases like tooth
decay, cure diseases like athlete's foot and, with a doctor's guidance, help manage
recurring conditions like vaginal yeast infection, migraine and minor pain in arthritis.
The U.S. Food and Drug Administration (FDA) determines whether medicines are
prescription or nonprescription. The term prescription (Rx) refers to medicines that are
safe and effective when used under a doctor's care. Nonprescription or OTC drugs are
medicines FDA decides are safe and effective for use without a doctor's prescription.
FDA also has the authority to decide when a prescription drug is safe enough to be sold
directly to consumers over the counter. This regulatory process allowing Americans to take
a more active role in their health care is known as Rx-to-OTC switch. As a result of this
process, more than 700 products sold over the counter today use ingredients or dosage
strengths available only by prescription 30 years ago.
Increased access to OTC medicines is especially important for our maturing population.
Two out of three older Americans rate their health as excellent to good, but four out of
five report at least one chronic condition.
Fact is, today's OTC medicines offer greater opportunity to treat more of the aches and
illnesses most likely to appear in our later years. As we live longer, work longer, and
take a more active role in our own health care, the need grows to become better informed
The best way to become better informed—for young and old alike—is to read and
understand the information on OTC labels. Next to the medicine itself, label comprehension
is the most important part of self-care with OTC medicines.
With new opportunities in self-medication come new responsibilities and an increased
need for knowledge. FDA and the Consumer Healthcare Products Association (CHPA) have
prepared the following information to help Americans take advantage of self-care
opportunities. back to top
OTC Know-How: It's on the Label
You wouldn't ignore your doctor's instructions for using a prescription drug; so don't
ignore the label when taking an OTC medicine. Here's what to look for:
- PRODUCT NAME
- "ACTIVE INGREDIENTS": therapeutic substances in
- "PURPOSE": product category (such as
antihistamine, antacid, or cough suppressant)
- "USES": symptoms or diseases the product will
treat or prevent
- "WARNINGS": when not to use the product, when to
stop taking it, when to see a doctor, and possible side effects
- "DIRECTIONS": how much to take, how to take it,
and how long to take it
- "OTHER INFORMATION": such as storage
- "INACTIVE INGREDIENTS": substances such as
binders, colors, or flavoring
You can help yourself read the label too. Always use enough light. It usually takes
three times more light to read the same line at age 60 than at age 30. If necessary, use
your glasses or contact lenses when reading labels.
Always remember to look for the statement describing the tamper-evident feature(s)
before you buy the product and when you use it.
When it comes to medicines, more does not necessarily mean better. You should never
misuse OTC medicines by taking them longer or in higher doses than the label recommends.
Symptoms that persist are a clear signal it's time to see a doctor.
Be sure to read the label each time you purchase a product. Just because two or more
products are from the same brand family doesn't mean they are meant to treat the same
conditions or contain the same ingredients.
Remember, if you read the label and still have questions, talk to a doctor, nurse, or
pharmacist. back to top
Drug Interactions: A Word to the Wise
Although mild and relatively uncommon, interactions involving OTC drugs can produce
unwanted results or make medicines less effective. It's especially important to know about
drug interactions if you're taking Rx and OTC drugs at the same time.
Some drugs can also interact with foods and beverages, as well as with health
conditions such as diabetes, kidney disease, and high blood pressure.
Here are a few drug interaction cautions for some common OTC ingredients:
- Avoid alcohol if you are taking antihistamines, cough-cold products with the
ingredient dextromethorphan, or drugs that treat sleeplessness.
- Do not use drugs that treat sleeplessness if you are taking prescription sedatives
- Check with your doctor before taking products containing aspirin if you're taking a
prescription blood thinner or if you have diabetes or gout.
- Do not use laxatives when you have stomach pain, nausea, or vomiting.
- Unless directed by a doctor, do not use a nasal decongestant if you are taking a
prescription drug for high blood pressure or depression, or if you have heart or thyroid
disease, diabetes, or prostate problems.
This is not a complete list. Read the label! Drug labels change as new information
becomes available. That's why it's important to read the label each time you take
medicine. back to top
Time for a Medicine Cabinet Checkup?
- Be sure to look through your medicine supply at least once a year.
- Always store medicines in a cool, dry place or as stated on the label.
- Throw away any medicines that are past the expiration date.
- To make sure no one takes the wrong medicine, keep all medicines in their original
containers. back to top
Pregnancy and Breast-Feeding
Drugs can pass from a pregnant woman to her unborn baby. A safe amount of medicine for
the mother may be too much for the unborn baby. If you're pregnant, always talk with your
doctor before taking any drugs, Rx or OTC.
Although most drugs pass into breast milk in concentrations too low to have any
unwanted effects on the baby, breast-feeding mothers still need to be careful. Always ask
your doctor or pharmacist before taking any medicine while breast-feeding. A doctor or
pharmacist can tell you how to adjust the timing and dosing of most medicines so the baby
is exposed to the lowest amount possible, or whether the drugs should be avoided
altogether. back to top
Kids Aren't Just Small Adults
OTC drugs rarely come in one-size-fits-all. Here are some tips about giving OTC
medicines to children:
- Children aren't just small adults, so don't estimate the dose based on their size.
- Read the label. Follow all directions.
- Follow any age limits on the label.
- Some OTC products come in different strengths. Be aware!
- Know the difference between TBSP. (tablespoon) and TSP. (teaspoon). They are very
- Be careful about converting dose instructions. If the label says two teaspoons, it's
best to use a measuring spoon or a dosing cup marked in teaspoons, not a common kitchen
- Don't play doctor. Don't double the dose just because your child seems sicker than
- Before you give your child two medicines at the same time, talk to your doctor or
- Never let children take medicine by themselves.
- Never call medicine candy to get your kids to take it. If they come across the
medicine on their own, they're likely to remember that you called it candy.
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Child-resistant closures are designed for repeated use to make it difficult for
children to open. Remember, if you don't re-lock the closure after each use, the
child-resistant device can't do its job—keeping children out!
It's best to store all medicines and dietary supplements where children can neither see
nor reach them. Containers of pills should not be left on the kitchen counter as a
reminder. Purses and briefcases are among the worst places to hide medicines from curious
kids. And since children are natural mimics, it's a good idea not to take medicine in
front of them. They may be tempted to "play house" with your medicine later on.
If you find some packages too difficult to open—and don't have young children living
with you or visiting—you should know the law allows one package size for each OTC medicine
to be sold without child-resistant features. If you don't see it on the store shelf, ask.
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Protect Yourself Against Tampering
Makers of OTC medicines seal most products in tamper-evident packaging (TEP) to help
protect against criminal tampering. TEP works by providing visible evidence if the package
has been disturbed. But OTC packaging cannot be 100 percent tamper-proof. Here's how to
help protect yourself:
- Be alert to the tamper-evident features on the package before you open it. These
features are described on the label.
- Inspect the outer packaging before you buy it. When you get home, inspect the
- Don't buy an OTC product if the packaging is damaged.
- Don't use any medicine that looks discolored or different in any way.
- If anything looks suspicious, be suspicious. Contact the store where you bought the
product. Take it back!
- Never take medicines in the dark.
This material is distributed as a public service by:
The U.S. Food and Drug Administration and the Consumer Healthcare Products
Association (CHPA), a national organization representing companies dedicated to
providing consumers with safe and effective over-the-counter (OTC) medicines and dietary
supplements and the information to use them properly.
For free single or bulk quantities of the printed pamphlet, contact:
Consumer Healthcare Products Association
900 19th Street, NW, Suite 700
Washington, DC 20006
Or email your request to www.chpa-info.org
Consumer Education: Over-the-Counter Medicine
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Date created: March 7, 2006