ASPIRIN SAFETY COATED ENTERIC, REGULAR STRENGTH- aspirin tablet, coated 
COSTCO WHOLESALE CORPORATION

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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Kirkland 44-227-Delisted

Active ingredient (in each tablet)

Aspirin 325 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains due to:
    • colds
    • muscle pain
    • headache
    • toothache
    • menstrual pain
    • minor pain of arthritis
  • or as recommended by a 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:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • 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 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
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

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 (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 to 2 tablets every 4 hours while symptoms last
  • do not take more than 12 tablets in 24 hours unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • use by expiration date on package
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

black iron oxide, cellulose, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, 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

KIRKLAND
Signature

COMPARE TO
ECOTRIN®
active ingredient

NDC 63981-227-14
ITM. / ART. 197121

SAFETY COATED ENTERIC
ASPIRIN
Regular Strength

325 mg

✓Pain Reliever (NSAID)
Aspirin Regimen**

Actual Size

500
TABLETS

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

This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Ecotrin®.
50844          REV1113F22714

**Ask your doctor before taking this product on a regular basis.

This product does not contain gluten.

Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For Costco Wholesale Corporation
P.O. Box 34535
Seattle, WA 98124-1535 USA
1-800-774-2678        www.costco.com
 17V0279a

Kirkland 44-227

Kirkland 44-227

ASPIRIN  SAFETY COATED ENTERIC, REGULAR STRENGTH
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-227
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
STARCH, CORN (UNII: O8232NY3SJ)  
SHELLAC (UNII: 46N107B71O)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;227
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63981-227-14500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/14/199210/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34312/14/199210/01/2022
Labeler - COSTCO WHOLESALE CORPORATION (103391843)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(63981-227)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(63981-227)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088MANUFACTURE(63981-227) , PACK(63981-227)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(63981-227)

Revised: 1/2020
 
COSTCO WHOLESALE CORPORATION