all you wanted to know about the drug facts label
DESCRIPTION
And more…. All You Wanted to Know About the Drug FactS Label. 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. Who Regulates The Drug Facts Label?. - PowerPoint PPT PresentationTRANSCRIPT
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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 Drugs Facts Label provides consumers with important information about over-the counter medicine.
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Who RegulatesThe Drug Facts Label?
The US Food and Drug Administration (FDA) regulates the labeling of all over-the-counter medicines.
The content and the format make it easy for consumers to compare products.
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The Drug Facts Label must be:
Easy to readEasy to understandIn 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 haveDrug Facts Labels?
Not really, but they do have a “package insert” or a drug information sheet.
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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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Pharmacists can help
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Why should I pay attentionto 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 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 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
ingredientsAnd sometimes an optional section called:
• Questions?
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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/Purpose
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Drug Facts
Active ingredient (in each tablet) PurposeAcetaminophen 325mg………...Pain reliever/fever reducerChlorpheniramine 2mg………………………..AntihistamineDextromethorphan HBr 10m………… Cough suppressantPhenylephrine HCI 5 mg……………....Nasal decongestant
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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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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Be cautious
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Uses
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The symptoms the drug 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 medicine is designed to treat.
Use only the medicine that treats the symptoms you have.
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Warnings
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WarningsAlcohol 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
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. 20
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Directions
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How to use safely
Directionsadults 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 useHow to useHow 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
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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 information about other ingredients as required by the FDA
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How to store the medicine
Information about tamper resistant packaging
Ingredients that are neither active or inactive, such as sodium
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“Other” may include:
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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 dioxideComponents 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?
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An optional DFL feature
Questions or comments? call 1-877-895-3665 (English) or 1-888-466-8746 (Spanish)
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Call the toll free number
Telephone number to call for information or to 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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