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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 Who Regulates The Drug Facts Label? The US Food and Drug Administration (FDA) regulates the labeling of all overthe-counter medicines. The content and the format make it easy for consumers to compare products. 3 The Drug Facts Label must be: Easy to read Easy to understand In the same format on every over-thecounter medicine 4 Another Label – Vitamins, minerals, and herbs are labeled with the Dietary Supplement Label. They are not considered drugs. 5 Do prescription drugs have Drug Facts Labels? Not really, but they do have a “package insert” or a drug information sheet. 6 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. 7 Why should I pay attention to the Drug Facts Label? The Drug Facts Label helps you use OTC medicine correctly and safely. 8 Important information is on the Drug Facts Label Following the label is the best way to stay safe and protect your health. 9 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. 10 What information does it include? The Drug Facts Label includes: • Active Ingredient(s)/Purpose • Warnings 11 The Drug Facts Label also includes: Directions Other information Inactive ingredients And sometimes an optional section called: • Questions? • • • 12 A Closer Look All of this information is important, yet many people never read the Drug Facts Label. So, let’s take a look… 13 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 Active Ingredients/ Purpose What makes the drug work What it does 14 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. 15 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. 16 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 17 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. 18 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 Special concerns regarding use 19 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 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 21 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 22 Dosage The strength of the medicine depends on the amount of active ingredient in each dose. Use an accurate measuring tool for liquid medicine. 23 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 24 “Other” may include: How to store the medicine Information about tamper resistant packaging Ingredients that are neither active or inactive, such as sodium 25 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 Inactive ingredients Components of the medicine that do not treat illness 26 Excipients Inactive ingredients make up the pill or liquid that caries the active ingredient(s). In pharmaceutical terms they are called excipients. 27 Questions or comments? call 1-877895-3665 (English) or 1-888-466-8746 (Spanish) Questions? An optional DFL feature 28 Call the toll free number Telephone number to call for information or to comment on the product Some OTC medicines include Web addresses 29 If you are ever unsure about how or when to use medicine, consult your doctor or another health care professional. 30 Make Medicine Use SAFER The FDA recommends: Speak Up Ask Questions Find the Facts Evaluate Choices Read the Label 31