Understanding
DRUG LABELS
Belen G. De los Trinos, RN,RM,USRN,MAN
• A drug label refers to all the printed
information included with any dietary
supplement, over-the-counter medicine, or
prescription drug. They’re strictly
regulated by the Food and Drug
Administration and provide plenty of useful
information savvy healthcare investors use
to evaluate a company's products
Objective
To be able to read and understand the
labels of the medication you have available.
Pertinent Information on a
Drug Label
• Brand and Generic Names
• Dosage strength
• Form
• Supply dosage
• Total volume
• Administration route
• Directions for mixing or reconstituting
• Label alerts
• Name of manufacturer
Pertinent Information on a
Drug Label
•Expiration date
•Lot or control number
•National drug code (NDC)
•Bar code symbols
•United States Pharmacopeia (USP) and National
Formulary (NF)
•Unit or single-dose labels
•Combination drugs
•Supply dosage expressed as a ratio or percent
BRAND AND GENERIC NAMES
• The brand, trade, or proprietary name is the
manufacturer’s name for the drug.
– Usually the most prominent word on the drug label –
bold, large type
– Often followed by the registered sign ® or ™
• The generic or non-proprietary name appears
directly under the brand name or placed inside
a parenthesis
– By law, the generic name must be identified on all
drug labels
DOSAGE STRENGTH
• Refers to the dosage weight or amount of
drug provided in a specific unit of
measurement.
FORM
• This identifies the structure and composition of the
drug
• solid dosage forms for oral use include tablets and
capsules
• some powdered or granular medications that are not
manufactured in tablet or capsule form can be directly
combined with food or beverages and administered
• others must be reconstituted (liquefied) and
measured in a precise liquid volume, such as
milliliters, drops, or ounces
FORM
• they maybe a crystalloid (clear solution) or a
suspension (solid particles in liquid that
separate when held in a container)
• injectable medications may be supplied in
solution or dry powdered form to be
reconstituted. Once reconstituted, they are
measured in milliliters
• medications are also supplied in a variety of
other forms, such as suppositories, creams
and patches
SUPPLY DOSAGE
• Refers to both dosage strength and form
• it is read X measured units per some
quantity
o for solid form medications such as tablets, the
supply dosage is X measured units per tablet
Example: 250 mg/tablet; 100 mg/capsule
o for liquid medications, the supply dosage is X
measured units per milliliter
Example: 500 mg/5mL; 250 mg/mL
SUPPLY DOSAGE
TOTAL VOLUME
• Refers to the full quantity contained in a
package, bottle, or vial
• For tablets and other solid medications – it
is the total number of individual items
• For liquids – it is the total fluid volume
ADMINISTRATION ROUTE
• Refers to the site of the body or method of
drug delivery
– Oral - Topical
– Enteral - Rectal
– Sublingual - Inhaled
– Injection
– Otic
– Optic
DIRECTIONS FOR MIXING OR
RECONSTITUTING
• Some drugs are dispensed in powder form
and must be reconstituted for use.
LABEL ALERTS
• Refers to warnings on the packaging or special
alerts before dispensing. Look for alerts such as
“refrigerate at all times,” “keep in dry place,”
“shake well before using”
NAME OF THE MANUFACTURER
EXPIRATION DATE
• The medication should be used,
discarded, returned to the pharmacy
• Note expiration instructions given on
labels for reconstituted medications
Expiration instructions
LOT OR CONTROL NUMBERS
• Federal law requires all medication
packages to be identified with a lot or
control number
• If drug is recalled, for reasons such as
damage or tampering, the lot number
quickly identifies the particular group of
medication packages to be removed from
the shelves.
NATIONAL DRUG CODE
• Federal law requires every medication to
have a unique identifying number. This
number is printed with letters “NDC”
followed by three discrete groups of
numbers
CONTROLLED SUBSTANCE
SCHEDULE
• It’s purpose is to improve the administration and
regulation of the production, distribution and
dispensing of controlled substances
• Drugs are scheduled into numbered levels or
schedules from Schedule I to schedule V
BAR CODE SYMBOLS
• Commonly used in retail sales.
• Document drug dosing for recordkeeping and
stock reorder and can automate medication
documentation right at the patient’s bedside.
USP and NF
US Pharmacopeia & National Formulary
• The USP and NF are the two official lists
of approved drugs.
UNIT- or SINGLE-DOSE LABELS
COMBINATION DRUGS
• A combination of two or more drugs in one
form
SUPPLY DOSAGE EXPRESSED AS A
RATIO OR PERCENT
Contains 1 g pure drug per 1,000
mL solution
Contains 2 g pure drug
per 100 mL solution
• QUIZ – INTERPRETING DRUG LABELS
