LOW DOSE ASPIRIN - aspirin tablet
L.N.K. International, Inc.

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 ingredients (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Warnings

Reye's syndrome: Children and tennagers 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
take more or for a longer time than directed
have 3 or more alcoholic drinks every day while using this product
take other drugs containing prescription or nonprescription NSAIDs [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 asthma
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
- 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, 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)
see end flap for expiration date and lot number

Inactive ingredients

black iron oxide, corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, ploydextrose, polyethylene glycol, propylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, tracetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

Quality Plus

NDC 50844-563-32

†Compare to the active ingredient in Bayer® Low Dose Aspirin

LOW DOSE

Aspirin 81 mg

Pain Reliever (NSAID) ASPIRIN REGIMEN

120 Enteric Coated Tablets Safety Coated

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

50844 ORG041160032

Distributed by LNK INTERNATIONAL, INC.

60 Arkay Drive, Hauppauge, NY 11788

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

B-1603-600-32 ORG0411

LOW DOSE ASPIRIN
aspirin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50844-563
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
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIACETIN

Product Characteristics
Color	YELLOW	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	L
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:50844-563-32	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX	contains a BOTTLE, PLASTIC
1		120 TABLET (120 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the BOX (50844-563-32)
2	NDC:50844-563-17	1 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX	contains a BOTTLE, PLASTIC
2		300 TABLET (300 TABLET) in 1 BOTTLE, PLASTIC	This package is contained within the BOX (50844-563-17)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	05/02/2011

Labeler - L.N.K. International, Inc. (038154464)

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		832867894	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
LNK International, Inc.		038154464	PACK

Revised: 06/2012 L.N.K. International, Inc.