And more 1 What is the Drug Facts Label Modeled after the Nutrition Facts Label the Drugs Facts Label provides consumers with important information about OvertheCounter medicine 2 ID: 731538
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All You Wanted to Know About the Drug FactS Label
And more…
1Slide2
What is the
Drug Facts Label
?
Modeled after the
Nutrition Facts Label
, the Drugs Facts Label provides consumers with important information about Over-the-Counter medicine.
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OTC
Over-the-Counter medicine—medicine you buy off-the-shelf without a doctor’s order.
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Who Regulates the Drug Facts Label?
The US
Food and Drug Administration (FDA) regulates the labeling of all Over-the-Counter medicines.
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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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Some people do not understand
“More is not better”They need to take medicine as directed on the Drug Facts LabelEven OTC drugs can cause serious illness or even be fatal if taken incorrectly
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The OTC user is responsible to
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Self-diagnoseSelf-treat
Self-manage their medicine and their illnessSlide8
Important information
is on the Drug Facts 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 do not need 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
Uses
Warnings
Directions
Inactive ingredients
Other information
Questions or comments
?
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All of this information is important, yet many people never read the Drug Facts Label.
So, let’s take a look…
A Closer Look
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Active Ingredients/
Purpose12
Drug Facts
Active ingredient (in each tablet)
Purpose
Acetaminophen 325mg………...Pain reliever/fever reducer
Chlorpheniramine 2mg………………………..Antihistamine
Dextromethorphan HBr 10m………… Cough suppressant
Phenylephrine HCI 5 mg……………....Nasal decongestant
Ingredients that make the medicine work
What the ingredients doSlide13
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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Uses
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The symptoms the medicine will treat
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
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What is it good for?
The
Uses section explains the illness or symptoms the drug is designed to treat.Use only the medicine that treats the symptoms you have.
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Warnings
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Warnings
Alcohol Warning
: If you consume 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, persists 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).
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 as 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 ■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
Safety informationSlide17
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
Q
uestions
to ask a doctor before taking the drug
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Drug Interaction
Other medicines, supplements, medical conditions, and foods affect the way drugs work in your bodyThe Warning Section of the
Drug Facts Label lists what medicines to avoid using at the same time
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Directions
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How to use safely
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
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Directions include:
How much to use or doseHow to use
How often to use How many times per dayHow many hours between doses
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Dose
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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Children are not small adults
When giving children medicine use their weight as a guide and use the dose measuring tool included with the medication.
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Other information
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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
How to store the medicine and other important factsSlide24
How to store the medicineInformation about tamper resistant packaging
Ingredients that are neither active nor inactive, such as sodium
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Other
may include:Slide25
Inactive ingredients
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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, sodium starch glycolate, sucralose, titanium dioxide
Components of the medicine that do not treat illnessSlide26
Questions or comments
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Call the company if you have a question about a specific medicine
Questions or comments?
call
1-877-895-3665
(English) or
1-888-466-8746
(Spanish)Slide27
Call the toll free number
Telephone number to call for information or to comment on the product
Some OTC medicines include Web addresses27Slide28
If you are ever unsure about how or when to use medicine, consult a pharmacist, a healthcare professional, or a Poison Control Center.
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Poison Control Centers Online at www.PoisonHelp.org
Free, confidential, expert medical advice 24 hours a day, seven days a week.
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