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Low Dose Aspirin by GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Medically reviewed on June 3, 2017

Dosage form: tablet, chewable
Ingredients: ASPIRIN 81mg
Labeler: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
NDC Code: 64092-150

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.

Healthcare 44-218 SJ

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 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:

  • 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
  • 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

Do not use
  • if you are allergic to aspirin or any other pain reliever/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
  • 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 (1-800-222-1222) 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

Call 1-800-426-9391

Principal Display Panel

HEALTHCARE

NDC 64092-150-36

81 mg LOW STRENGTH
Low Dose Aspirin
Pain Reliever (NSAID)
For Aspirin Regimen Users

For Minor Aches and Pains

Orange Flavored

Compare to the active
ingredient in St. Joseph®
81 mg Chewable Aspirin

36 CHEWABLE TABLETS

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

This product is not manufactured or distributed by St.
Josephs Health Products, LLC, owner of the registered
trademark St. Joseph® 81 mg Chewable Aspirin.
50844       REV0613C21807

Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
www.glwholesale.com

HEALTHCARE GUARANTEE
If you are not completely satisfied with this
product, regardless of reason, return your unused
portion to Great Lakes Wholesale for a full refund

Healthcare 44-218

LOW DOSE ASPIRIN 
aspirin tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
DEXTRATES 
SACCHARIN SODIUM 
FD&C YELLOW NO. 6 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize8mm
FlavorORANGEImprint Code44;218
Contains    
Packaging
#Item CodePackage Description
1NDC:64092-150-361 BOTTLE, PLASTIC in 1 CARTON
136 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/12/1990
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(64092-150)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(64092-150)

 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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