ASPIRIN - aspirin tablet, chewable
CARDINAL HEALTH

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

temporarily relieves minor aches and pains

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye"s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

hives
facial swelling
shock
asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

have had stomach ulcers or bleeding problems
are age 60 or older
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Do not use

if you have ever had an allergic to aspirin or any other pain reliever or fever reducer
for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Ask a doctor before use if

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis or kidney disease
you have asthma
user takes a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout
diabetes
arthritis

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
new symptoms occur
ringing in the ears or loss of hearing occurs
pain gets worse or lasts more than 10 days
redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

In case of overdose, In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tabletsin 24 hours or as directed by a doctor.
children under 12: do not use unless directed by a doctor

Other information

store at controlled room temperature 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive ingredients

dextrates, ethylcellulose, FD&C yellow #6 aluminum lake, orange flavor, sodium saccharin, starch

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NDC 37205-369-68

LEADER®

SEE NEW WARNINGS INFORMATION

Compare to St. Joseph® active ingredient†

Aspirin

Pain reliever (NSAID)

81 mg Chewable

Adult Low Strength Aspirin Regimen

Orange Flavored

36 TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

50844 REV0310D21807

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

CIN 3510955 www.myleader.com 1-800-200-6313

Product Packaging

ASPIRIN
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-218
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (ASPIRIN)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTRATES
ETHYLCELLULOSES
FD&C YELLOW NO. 6

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	8mm
Flavor	ORANGE	Imprint Code	44;218
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:37205-218-23	1 BOTTLE (1 BOTTLE) in 1 CARTON	contains a BOTTLE
1		72 TABLET, CHEWABLE (72 TABLET) in 1 BOTTLE	This package is contained within the CARTON (37205-218-23)
2	NDC:37205-218-07	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON	contains a BOTTLE, PLASTIC
2		36 TABLET, CHEWABLE (36 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the CARTON (37205-218-07)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	09/12/1990

Labeler - CARDINAL HEALTH (097537435)

Revised: 06/2011 CARDINAL HEALTH