ASPIRIN- aspirin tablet, film coated
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.

----------

Leader 44-157 Delisted

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves:
- headache
- pain and fever of colds
- muscle pain
- toothache
- menstrual pain
- minor pain of arthritis

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
asthma (wheezing)
shock

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

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

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

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

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
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present
any new symptoms occur
ringing in the ears or loss of hearing occurs

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, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours
children under 12 years: ask a doctor

Other information

use by expiration date on package
store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn starch, hypromellose, polyethylene glycol, propylene glycol

Questions or comments?

1-800-426-9391

Principal display panel

NDC 37205-668-87

LEADER®

†Compare to Genuine Bayer® Aspirin active ingredient

GENUINE
Aspirin
325 mg

Pain Reliever/Fever Reducer
(NSAID)
Fast, Safe Pain Relief

300 COATED TABLETS

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

†This product is not manufactured or distributed by Bayer® HealthCare LLC, owner of the registered trademark Genuine Bayer® Aspirin.
50844 ORG091315717

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

CIN 4556783

All Leader® Brand Products are
100% satisfaction guaranteed or return
to place of purchase for a full refund.

Leader 44-157-17-UPC

ASPIRIN
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-668
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	ASPIRIN;157
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37205-668-78	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/1996	08/28/2020
2	NDC:37205-668-87	300 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/1996	08/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part343	02/10/1996	08/28/2020

Labeler - CARDINAL HEALTH (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(37205-668)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	MANUFACTURE(37205-668)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(37205-668)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(37205-668)

Revised: 10/2017

Document Id: e58b6263-48ac-4901-9ec7-cab75277af1b

Set id: 4f7aa599-ee07-401d-8d14-94a002367b16

Version: 4

Effective Time: 20171006

CARDINAL HEALTH