Transcript All You Wanted to Know About the Drug Fact Label

ALL YOU WANTED TO
KNOW ABOUT THE
DRUG FACTS LABEL
And more…
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What is the
Drug Facts Label?
Modeled after the Nutrition Facts Label, the Drug
Facts Label provides consumers with important
information about over-the counter medicine.
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Who Regulates The Drug Facts
Label?
The FDA regulates
the labeling of all
over-the-counter
medicines.
 The content and the
format makes it easy
for consumers to
compare products.

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The Drug Facts Label must be:
 Easy
to read
 Easy to understand
 In the same format on every
over-the-counter medicine
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Another Label
Vitamins, minerals, and herbs
are labeled with the Dietary
Supplement Label.
 They are not considered
drugs.

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Do prescription drugs have
Drug Facts Labels?
Not really, but they do have a “package insert” or
a drug information sheet.
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Pharmacists can help
Because prescriptions are
filled at a pharmacy, the
pharmacist can answer
questions about your
medicine.
 They are available to
answer questions about
OTC drugs, too.

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Why should I pay attention to
the Drug Facts Label?
The Drug Facts Label helps you use OTC
medicine correctly and safely.
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Important information is on the label

Following the label is
the best way to stay
safe and protect your
health.
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Where is the label located?
Look for the Drug Facts Label on the medicine
container or package. You should not have to
open the packaging to read the label.
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What information does it
include?
The Drug Facts Label includes:
•Active Ingredient(s)/Purpose
•Warnings
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The Drug Facts Label also includes:
•
•
•
•
Directions
Other information
Inactive ingredients
Questions?  (this is
an optional section)
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A Closer Look
 All
of this information is important,
yet many people never read the Drug
Facts Label.
So, let’s take a look…
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Drug Facts
Active ingredient (in each tablet)
Purpose
Acetaminophen 325mg……… .Pain reliever/fever reducer
Chlorpheniramine2mg…………………… ….Antihistamine
Dextromethorphan HBr 10m………… Cough suppressant
Phenylephrine HCI 5 mg………… ...Nasal decongestant
Active
ingredients/
Purpose
What makes the drug work
What it does
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Too much can hurt you
Check the active
ingredients in all
medicines.
 Don’t use two
medicines with the
same active
ingredient at the
same time.
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Be cautious
If the medicine contains
more than one active
ingredient, read the
purpose of each.
 Make sure you need
each active ingredient, if
you don’t, choose a
different drug.
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Uses ■temporarily relieves these common
cold symptoms:
■minor aches and pains ■headache
■sore throat ■cough ■sneezing and runny
nose ■helps clear nasal passages
■relieves cough to help you sleep
■temporarily reduces fever
Uses
The symptoms the drug will treat
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What is it good for?
The uses section
explains the illness or
symptoms the medicine
is designed to treat.
 Use only the medicine
that treats the
symptoms you have.

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Warnings
Alcohol Warning: If you consumer 3 or more alcoholic drinks every day, ask your
doctor whether you should take acetaminophen or other pain relievers or fever
reducers. Acetaminophen may cause liver damage.
Sore Throat warning: If sore throat is severe, persist for more than 2 days, is
accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a
doctor promptly.
Do not use ■with any other product containing acetaminophen ■if you are now taking
a prescription monamine oxidase inhibitor (MAOI)(certain drugs for depression,
psychiatric or emotional conditions, or Parkinson’s disease),
Warnings
Ask a doctor before use if you have ■heart disease
■high blood pressure ■thyroid disease ■diabetes
■trouble urinating due to an enlarged prostate
■persistent or chronic cough such a s occurs with smoking, asthma or emphysema
■cough that occurs with too much phlegm (mucus) ■a breathing problem such as
emphysema or chronic bronchitis ■glaucoma
When using this product ■do not exceed recommended dosage occur ■excitability
may occur, especially in children ■Alcohol, sedatives and tranquilizers may increase
drowsiness ■avoid alcoholic drinks ■be careful when driving a motor vehicle or
operating machinery
Stop use and ask a doctor if ■nervousness, dizziness, or sleeplessness occur
■pain, nasal congestion, or cough gets worse or lasts more than 7 days ■fever gets
worse or lasts more than 3 days ■redness or swelling is present
Special concerns regarding use
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Watch for side effects
Medicines often have
side effects —
unwanted or
unexpected effects on
the body.
 Read about the reasons
the medicine should
not be used, when to
consult a doctor, and
when to stop using it.
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Directions
adults and children12 years and over:■ take
4 to 8 tablets every 4 hours, ■swallow whole
– do not crush, chew or dissolve ■do not
take more than 12 caplets in 24 hours
■children under 12 years: do not use this
adult product in children under 12 years of
age, this will provide more than the
recommended dose (overdose) and may
cause liver damage
Directions
How to use safely
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Directions include:
How much to use
 How to use
 How often to use
◦ How many times per day
◦ How many hours between doses
 How long to use
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Dosage
The strength of the
medicine depends on
the amount of active
ingredient in each
dose.
 Use an accurate
measuring tool for
liquid medicine.
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Other information
■store at room temperature 20˚-35˚ C (68˚-77˚F)
■do not use if carton is opened or if blister
unit is broken■see side panel for lot number
and expiration date
Other
information
How to store the medicine and information
about other ingredients as required by the FDA
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“Other” may include:
How to store the
medicine
 Information about
tamper resistant
packaging
 Ingredients that are
neither active or
inactive such as
sodium
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Inactive ingredients anhydrous citric acid,
carnauba wax, corn starch, FD&C blue #1
aluminum lake, flavors, hypromellose, iron
oxide, magnesium stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate
80, potassium sorbate, powdered cellulose,
pregelatinized starch, propylene glycol
shellac, sodium benzoate, sodium citrate,
sodiuk starch glycolate, sucralose, titanium
dixoide
Inactive
ingredients
Components of the medicine that do not treat
illness
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Excipients
Inactive ingredients
make up the pill or
liquid that caries the
active ingredient(s).
 In pharmaceutical
terms they are called
excipients.
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Questions or comments? call 1-877895-3665 (English) or 1-888-466-8746
(Spanish)
Questions?
An optional DFL feature
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Call the toll free number
Telephone number to call
for information or
comment on the product
 Some OTC medicines
include web addresses
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If you are ever
unsure about how
or when to use
medicine, consult
your doctor or
another health
care professional.
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Make Medicine Use SAFER
The FDA recommends:
 Speak Up
 Ask Questions
 Find the Facts
 Evaluate Choices
 Read the Label
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