ENTERIC ASPIRIN- aspirin tablet, coated
WALGREEN CO.

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

for the temporary relief of minor aches and pains due to:
- headache
- muscle pain
- toothache
- menstrual pain
- the common cold
- minor pain of arthritis
or as recommended by your doctor

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

take a blood thinning (anticoagulant) or steroid drug

are age 60 or older

have 3 or more alcoholic drinks every day while using this product

take more or for a longer time that directed

take other drugs containing prescription or nonperscription NSAIDs [acetaminohen, aspirin, ibuprofen, naproxen or others]

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 have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you have ashtma
you are taking 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
- vomit blood
- have bloody or black stools
- 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 hearin goccurs
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swellin gis present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially imprtant 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 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, not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: do not use unless directed by a doctor

Other information

store at controlled room temperature 15º-30ºC (59º-86ºF)
avoid excessive heat and humidity
see end flap for expiration date and lot number

Inactive ingredients

black iron oxide, colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminim lake, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, shellac wax, simethicone, sodium alginate, sodium bicarbonate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

Walgreens

NDC 0363-0439-29

Compare to Ecotrin® 81mg Low Strength Enteric Coated Aspirin active ingredent†

NEW

ENTERIC

ASPIRIN

PAIN RELIEVER (NSAID)

FOR ASPIRIN REGIMEN USERS

EASY TO SWALLOW

150 TABLETS

81 mg SAFETY COATED

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, owner of the registered trademark Ecotrin® 81mg Low Strength Enteric Coated Aspirin.

50844 REV0510B43929

Distributed by: Walgreen Co.,

200 Wilmot Rd., Deerfield, IL 60015-4616

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

ITEM 500745

439-29

ENTERIC ASPIRIN
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0439
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
FERROSOFERRIC OXIDE
SODIUM BICARBONATE
TALC

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

Packaging
#	Item Code	Package Description
1	NDC:0363-0439-29	1 in 1 CARTON
1		150 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	04/14/2004

Labeler - WALGREEN CO. (008965063)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(0363-0439)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(0363-0439)

Revised: 08/2012

Document Id: ab0985bd-2491-46c1-b46d-3b4541c475f5

Set id: f517ce40-b4fa-4d03-a568-b3c23e1cfbd4

Version: 1

Effective Time: 20120802

WALGREEN CO.