1. All You Wanted to Know About the Drug FactS Label
And more…

2. 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.

3. OTC
Over-the-Counter medicine— medicine you buy off-the-shelf without a doctor’s order.
It should seem obvious, but many people do not consider over-the-counter medicines real drugs.

4. Who Regulates the Drug Facts Label?
The US Food and Drug Administration (FDA) regulates the labeling of all Over-the-Counter medicines.
The Drug Facts Label must be:
Easy to read
Easy to understand
In the same format on every Over-the-Counter medicine
The content and the format make it easy for consumers to compare products.

5. Why should I pay attention to the Drug Facts Label?
The Drug Facts Label helps you use OTC medicine correctly and safely.

6. 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
More than the recommended dose will not provide greater or better relief from symptoms.
Reading the Drug Facts Label is the important first step when taking OTCs.

7. The OTC user is responsible to
Self-diagnose
Self-treat
Self-manage their medicine and their illness
The consumer takes responsibility for self care. Your pharmacist, doctor, or nurse can help you select an appropriate OTC if you have any doubts.

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 do not need to open the packaging to read the label.

10. What information does it include?
The Drug Facts Label includes:
Active Ingredient(s)/Purpose
Uses
Warnings
Directions
Inactive ingredients
Other information
Questions or comments?

11. A Closer Look
All of this information is important, yet many people never read the Drug Facts Label.
So, let’s take a look…

12. Active Ingredients/ Purpose
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
Ingredients that make the medicine work
What the ingredients do

13. 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.
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.

14. Uses 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
The symptoms the medicine will treat

15. 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.
Use no more medicine than you need

16. Warnings Safety information 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
Warnings
Safety information

17. 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

18. 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
Before combining an OTC with a prescription medicine you should consult your doctor or pharmacist.

19. Directions 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
How to use safely

20. 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

21. Dose
The strength of the medicine depends on the amount of active ingredient in each dose.
Use an accurate measuring tool for liquid medicine.
Ask your pharmacist for a measuring tool if one does not come with the medication. Spoons are not accurate for measuring medicine.

22. 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.

23. Other information How to store the medicine and other important facts
■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

24. Other may include: How to store the medicine
Information about tamper resistant packaging
Ingredients that are neither active nor inactive, such as sodium

25. 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
Inactive ingredients make up the pill or liquid that caries the active ingredient(s). These include coloring and flavoring.
In pharmaceutical terms they are called excipients.
Components of the medicine that do not treat illness

26. Questions or comments
Questions or comments? call (English) or (Spanish)
The company phone number is found in this section.
Call the company if you have a question about a specific medicine

27. Call the toll free number
Telephone number to call for information or to comment on the product
Some OTC medicines include Web addresses

28. If you are ever unsure about how or when to use medicine, consult a pharmacist, a healthcare professional, or a Poison Control Center.
Expert advice, free, confidential and available 24 hours per day, seven days per week.

29. Poison Control Centers Online at www.PoisonHelp.org
Free, confidential, expert medical advice 24 hours a day, seven days a week.