The New Over-the-Counter Medicine Label: Take a
Look
Graphic version in
PDF format
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Always Read the Label
Reading the
product label is the most
important part of taking care
of yourself or your
family when using
over-the-counter (OTC) medicines (available
without a prescription).
This is especially true because
many OTC medicines are
taken without seeing a
doctor. The OTC medicine label has always
contained important usage and
safety information for
consumers, but now that
information will be more consistent and
even easier to read and to
understand. The U.S.
Food and Drug Administration
(FDA) has issued a regulation
to make sure the labels
on all OTC medicines (from a tube
of fluoride toothpaste to a
bottle of cough syrup)
have information listed in the same
order; are arranged in a
simpler eye-catching,
consistent style; and may contain easier to
understand words.
While the new labels on a
majority of OTC drug
products will be appearing on store
shelves soon, some products and
companies have
additional time to comply with the new
labeling regulations. If you
read the OTC medicine
label and still have questions
about the product, talk to your
doctor, pharmacist, or
other health care professional.
Tamper-Evident Packaging: An Important Safety Feature
The makers of OTC medicines widely
use tamper-evident packaging for their products. This is to help protect consumers against
possible criminal tampering. Drug products with tamper-evident packaging have a statement
on the packaging describing this safety feature. It is always important to inspect the
outer packaging before you buy an OTC drug product and to look at the product again before
you take it.
What's On The New Label
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All nonprescription, over-the-counter (OTC)
medicine labels have detailed usage and warning information so consumers can properly
choose and use the products.
Below is an example of what the new OTC medicine
label looks like.
- Active Ingredient. Therapeutic substance
in product; amount of active ingredient per unit.
- Uses. Symptoms or diseases the product will treat or prevent.
- Warnings. When not to use the
product; conditions that may require advice from a doctor before taking the product;
possible interactions or side effects; when to stop taking the product and when to
contact a doctor; if you are pregnant or breastfeeding, seek guidance from a health care
professional; keep product out of children’s reach.
- Inactive Ingredients. Substances
such as colors or flavors.
- Purpose. Product action or
category (such as antihistamine, antacid, or cough suppressant.
- Directions. Specific age
categories, how much to take, how to take, and how often and how long to take.
- Other Information. How to store
the product properly and required information about certain ingredients (such as the
amount of calcium, potassium, or sodium the product contains)
The new Drug Facts labeling requirements do not apply to dietary supplements, which
are regulated as food products, and are labeled with a Supplement Facts panel.
![Drug label with Drug Facts sections](graphics/OTC-label.gif)
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Reading the Label: The Key to Proper Medicine Use
The label tells you what a medicine is supposed to do, who should or
should not take it, and how to use it. But efforts to provide good labeling can't
help unless you read and use the information. It's up to you to be informed and to
use OTC drug products wisely and responsibly.
The manufacturers of OTC medicines sometimes make changes to their
products or labeling (new ingredients, dosages, or warnings). Make sure to read the
label each time you use the product. Always look for special "flags" or "banners" on
the front product label alerting you to such changes. If you read the label and
still have questions, ask your doctor, pharmacist, or other health care professional for
advice.
The Label Also Tells You...
-
The expiration date, when applicable (date after which you should
not use the product).
-
Lot or batch code (manufacturer information to help identify the
product).
-
Name and address of manufacturer, packer, or distributor.
-
Net quantity of contents (how much of the product is in each
package).
-
What to do if an overdose occurs.
Many OTC medicines are sold in containers with child safety closures. Use
them properly. Remember—keep all medicines out of the sight and reach of children.
FDA
U.S. Food and Drug Administration
Phone: 1-888-INFO-FDA (1-888-463-6332)
CHPA
Consumer Healthcare Products Association
For free single or bulk quantities of the printed pamphlet, contact:
Consumer Healthcare Products Association
Publications Department
900 19th Street, NW, Suite 700
Washington, DC 20006
Or email your request to
www.chpa-info.org
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Date created: March 7, 2006 |