All You Wanted to Know About the Drug Facts Label
Modeled after the Nutrition Facts Label, the Drug Facts Label provides consumers with important information about Over-the-Counter medicine. Over-the-Counter (OTC) medicines, bought off-the-shelf without a doctor's order, are regulated by the US Food and Drug Administration (FDA). Paying attention to the Drug Facts Label is crucial for safe and correct usage of OTC medicine. It includes details such as active ingredients, uses, warnings, directions, inactive ingredients, and other important information. Remember, following the label is the best way to protect your health.
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Presentation Transcript
ALL YOU WANTED TO KNOW ABOUT THE DRUG FACTS LABEL 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 Over-the-Counter medicine. 2
OTC Over-the-Counter medicine medicine you buy off-the-shelf without a doctor s order. 3
Who Regulates the Drug Facts Label? The US Food and Drug Administration (FDA) regulates the labeling of all Over-the-Counter medicines. 4
Why should I pay attention to the Drug Facts Label? The Drug Facts Label helps you use OTC medicine correctly and safely. 5
Some people do not understand More is not better They need to take medicine as directed on the Drug Facts Label Even OTC drugs can cause serious illness or even be fatal if taken incorrectly 6
The OTC user is responsible to Self-diagnose Self-treat Self-manage their medicine and their illness 7
Important information is on the Drug Facts Label Following the label is the best way to stay safe and protect your health. 8
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. 9
What information does it include? The Drug Facts Label includes: Active Ingredient(s)/Purpose Uses Warnings Directions Inactive ingredients Other information Questions or comments? 10
A Closer Look All of this information is important, yet many people never read the Drug Facts Label. So, let s take a look 11
Drug Facts Active Ingredients/ Purpose Active ingredient (in each tablet) Acetaminophen 325mg ...Pain reliever/fever reducer Chlorpheniramine 2mg ..Antihistamine Dextromethorphan HBr 10m Cough suppressant Phenylephrine HCI 5 mg ....Nasal decongestant Purpose Ingredients that make the medicine work What the ingredients do 12
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. 13
Uses 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 The symptoms the medicine will treat 14
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. 15
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). 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 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 information 16
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 Questions to ask a doctor before taking the drug 17
Drug Interaction Other medicines, supplements, medical conditions, and foods affect the way drugs work in your body The Warning Section of the Drug Facts Label lists what medicines to avoid using at the same time 18
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 19
Directions include: How much to use or dose How to use How often to use How many times per day How many hours between doses 20
Dose The strength of the medicine depends on the amount of active ingredient in each dose. Use an accurate measuring tool for liquid medicine. 21
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. 22
Other information 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 facts 23
Other may include: How to store the medicine Information about tamper resistant packaging Ingredients that are neither active nor inactive, such as sodium 24
Inactive ingredients 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 illness 25
Questions or comments Questions or comments? call 1-877- 895-3665 (English) or 1-888-466-8746 (Spanish) Call the company if you have a question about a specific medicine 26
Call the toll free number Telephone number to call for information or to comment on the product Some OTC medicines include Web addresses 27
If you are ever unsure about how or when to use medicine, consult a pharmacist, a healthcare professional, or a Poison Control Center. 28
Poison Control Centers Online at www.PoisonHelp. org Free, confidential, expert medical advice 24 hours a day, seven days a week. 29
