CONTENTS

Advice for Americans AboutSelf-Care. . . . . 1

OTC Know-How: It’s on the Label . . . . . 4

Drug Interactions: A Word tothe Wise . . . . . 6

Time for a Medicine CabinetCheckup . . . . . 8

Pregnancy and Breast-Feeding . . . . . 9

Kids Aren’t Just Small Adults . . . 10

Protect Yourself Against Tampering . . .12

C H P AONSUMER EALTHCARE RODUCTS SSOCIATIONF O U N D E D 1 8 8 1

CHPAR

JP-12/03-150M FDA03-3224

Advancing Quality Healthcare ThroughOver-the-Counter Medicines and Nutritional Supplements

Distributed as a public service by theU.S. DEPARTMENT OF HEALTH AND

HUMAN SERVICESFood and Drug Administration

and theConsumer Healthcare Products Association

ADVICE FOR AMERICANSABOUT SELF-CARE

Access + Knowledge = Power

merican medicine cabi-

nets contain a growing

choice of nonprescrip-

tion, over-the-counter

(OTC) medicines to

treat an expanding

range of ailments.

OTC medicines often

do more than relieve

aches, pains and

itches. Some can

prevent diseases

like tooth decay,

cure diseases like athlete’s

foot and, with a doctor’s guid-

ance, help manage recurring conditions

like vaginal yeast infections, migraines

and minor pain in arthritis.

The U.S. Food and Drug Adminis-

tration (FDA) determines whether

medicines are prescription or nonpre-

scription. The term prescription (Rx)

refers to medicines that are safe and

A

11111

effective when used under a doctor’s

care. Nonprescription or OTC drugs are

medicines FDA decides are safe and

effective for use without a doctor’s

prescription.

FDA also has the authority to

decide when a prescription drug is safe

enough to be sold directly to consumers

over the counter. This regulatory pro-

cess allowing Americans to take a more

active role in their health care is known

as Rx-to-OTC switch. As a result of this

process, more than 700 products sold

over the counter today use ingredients

or dosage strengths available only by

prescription 30 years ago.

Increased access to

OTC medicines is espe-

cially important for our

maturing population. Two

out of three older Americans

rate their health as excellent

to good, but four out of five

report at least one chronic

condition.

Fact is, today’s OTC

medicines offer greater

opportunity to treat more of the aches

and illnesses most likely to appear in

22222

our later years. As we live longer, work

longer and take a more active role in

our own health care, the need grows to

become better informed about self-care.

The best way to become better

informed—for young and old alike—is to

read and understand the information on

OTC labels. Next to the medicine itself,

label comprehension is the most impor-

tant part of self-care with OTC

medicines.

With new opportunities in self-

medication come new responsibilities

and an increased need for knowledge.

FDA and the Consumer Healthcare

Products Association (CHPA) have

prepared the following information to

help Americans take advantage of self-

care options.

33333

OTC KNOW-HOW:IT’S ON THE LABEL

ou wouldn’t ignoreyour doctor’s instruc-tions for using aprescription drug, sodon’t ignore the labelwhen taking an OTCmedicine. Here’s what tolook for:

PRODUCT NAME

“ACTIVE INGREDIENTS”—therapeutic substances inmedicine

“PURPOSE”—product category(such as antihistamine, antacidor cough suppressant)

“USES”—symptoms or diseasesthe product will treat or prevent

“WARNINGS”—when not to usethe product, when to stop takingit, when to see a doctor andpossible side effects

“DIRECTIONS”—how much totake, how to take it, and howlong to take it

“OTHER INFORMATION”—suchas storage information

“INACTIVE INGREDIENTS”—substances such as binders,colors or flavorings

Y

44444

You can help yourself read thelabel too. Always use enough light. Itusually takes three times more light toread the same line at age 60 than at age30. If necessary, use your glasses orcontact lenses when reading labels.

Always remember to look for thestatement describing the tamper-evidentfeature(s) before you buy the product andwhen you use it.

When it comes to medicines, moredoes not necessarily mean better. Youshould never misuse OTC medicines bytaking them longer or in higher dosesthan the label recommends. Symptomsthat persist are a clear signal it’s time tosee a doctor.

Be sure to read the label each timeyou purchase a product. Just becausetwo or more products are from the samebrand family doesn’t mean they aremeant to treat the same conditions orcontain the same ingredients.

Remember, if you read the labeland still have questions, talk to adoctor, nurse or pharmacist.

55555

DRUG INTERACTIONS:A WORD TO THE WISE

lthough mild and relatively uncom-mon, interactions involving OTC drugscan produce unwanted results or makemedicines less effective. It’s especiallyimportant to know about drug interac-tions if you’re taking Rx and OTC drugsat the same time.

Some drugs can also interact withfoods and beverages, as well as withhealth conditions such as diabetes,kidney disease and high bloodpressure.

Here are few drug interactioncautions for some common OTCingredients:

Avoid alcohol if you are takingantihistamines, cough-coldproducts with the ingredientdextromethorphan or drugs thattreat sleeplessness.

Do not use drugs that treatsleeplessness if you are takingprescription sedatives ortranquilizers.

A

66666

Check with your doctor beforetaking products containingaspirin if you’re taking a pre-scription blood thinner or if youhave diabetes or gout.

Do not use laxatives when youhave stomach pain, nausea orvomiting.

Unless directed by a doctor, donot use a nasal decongestant ifyou are taking a prescriptiondrug for high blood pressure ordepression, or if you have heartor thyroid disease, diabetes orprostate problems.

This is not a complete list. Read thelabel! Drug labels change as new infor-mation becomes available. That’s whyit’s important to read the label each timeyou take medicine.

77777

TIME FOR A MEDICINECABINET CHECKUP

Be sure to look through yourmedicine supply at least oncea year.

Always store medicines in acool, dry place or as statedon the label.

Throw away any medicinesthat are past the expirationdate.

To make sure no one takesthe wrong medicine, keep allmedicines in their originalcontainers.

88888

PREGNANCY ANDBREAST-FEEDING

rugs can passfrom a pregnantwoman to herunborn baby.A safe amountof medicinefor themothermay betoo muchfor theunbornbaby. Ifyou’re pregnant, always talk with yourdoctor before taking any drugs, Rxor OTC.

Although most drugs pass intobreast milk in concentrations too low tohave any unwanted effects on the baby,breast-feeding mothers still need to becareful. Always ask your doctor orpharmacist before taking any medicinewhile breast-feeding. A doctor or phar-macist can tell you how to adjust thetiming and dosing of most medicines sothe baby is exposed to the lowestamount possible, or whether the drugsshould be avoided altogether.

99999

D

KIDS AREN’T JUSTSMALL ADULTS

TC drugs rarely come in one-size-fits-all. Here are some tips about giving OTCmedicines to children:

Children aren’t just small adults,so don’t estimate the dose.

Read the label. Follow alldirections.

Follow any age limits on the label.

Some OTC products come indifferent strengths. Be aware!

Know the difference betweenTBSP. (tablespoon) and TSP.(teaspoon). They are very differentdoses.

Be careful about converting doseinstructions. If the label says twoteaspoons, it’s best to use ameasuring spoon or a dosing cupmarked in teaspoons, not acommon kitchen spoon.

Don’t play doctor. Do not doublethe dose just because your childseems sicker than last time.

Before you give your child twomedicines at the same time, talkto your doctor or pharmacist.

Never let children take medicineby themselves.

O

1010101010

Never call medicine candy to getyour kids to take it. If they comeacross the medicine on theirown, they’re likely to rememberthat you called it candy.

CHILD-RESISTANT PACKAGING

Child-resistant closures are de-signed for repeated use to make it diffi-cult for children to open. Remember, ifyou don’t re-lock the closure after eachuse, the child-resistant device can’t do itsjob—keeping children out!

It’s best to store all medicines anddietary supplements where children canneither see nor reach them. Containers ofpills should not be left on the kitchencounter as a reminder. Purses andbriefcases are among the worst places tohide medicines from curious kids. Andsince children are natural mimics, it’s agood idea not to take medicine in front ofthem. They may be tempted to “playhouse” with your medicine later on.

If you find some packagestoo difficult to open—anddon’t have young childrenliving with you or visiting—you should know the lawallows one package sizefor each OTC medicineto be sold withoutchild-resistantfeatures. If youdon’t see it on thestore shelf, ask.

1111111111

PROTECT YOURSELFAGAINST TAMPERING

Makers of OTC medicinesseal most products intamper-evidentpackaging (TEP) tohelp protect againstcriminal tampering.TEP works by provid-ing visible evidence ifthe package has beendisturbed. But OTCpackaging cannot be100 percent tamper-

proof. Here’s how tohelp protect yourself:

Be alert to the tamper-evidentfeatures on the package before youopen it. These features are describedon the label.

Inspect the outer packaging beforeyou buy it. When you get home,inspect the medicine inside.

Don’t buy an OTC product if thepackaging is damaged.

Don’t use any medicine that looksdiscolored or different in any way.

If anything looks suspicious, besuspicious. Contact the storewhere you bought the product.Take it back!

Never take medicines in the dark.

1212121212

The Consumer Healthcare Products Association (CHPA)is a national organization representing companies dedi-cated to providing consumers with safe and effective over-the-counter (OTC) medicines and nutritional supplementsand the information to use them properly.

U.S. DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

DEPARTMENTO

FH

EA

LT

H&

HU

MAN SERVICES • USA

For free bulk quantities,

visit

www.chpa-info.org

C H P AONSUMER EALTHCARE RODUCTS SSOCIATION

F O U N D E D 1 8 8 1

CHPA