The New Over-the-Counter
Medicine Label: Take a Look
Always Read the Label
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
flouride toothpaste to a bottle of cough syrup)
have information listed in the same order;
are arranged in a simpler eyecatching, consistent
style; and may contain easier to understand
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
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.
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
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.
Substances such as colors or flavors.
action or category (such as antihistamine, antacid, or cough suppressant.
age categories, how much to take, how to take, and how often and how long
How to store the product properly and required information about certain
ingredients (such as the amount of calcium, potassium, or sodium the
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.
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
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
Name and address of manufacturer, packer, or distributor.
Net quantity of contents (how much of the product is in each
What to do if an overdose occurs.
Many OTC medicines are sold in containers with child safety
closures. Use them properly. Rememberkeep all medicines
out of the sight and reach of children.