Enteric Coated Asprin 81 mg

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-363

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.

Quality Choice 44-600

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 25ºC (77ºF); excursions permitted between 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

NDC 63868-363-20

QC
QUALITY CHOICE®

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

Enteric Coated
Aspirin Low Dose
Aspirin Regimen

Pain Reliever (NSAID)

120 Tablets (81 mg Each)

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 BAYER® Low Dose Aspirin.
50844    REV061360032

Quality Choice 44-600A

ENTERIC COATED ASPRIN 81 MG 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-363
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOWScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeL
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-363-201 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
1120 TABLET (120 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34305/02/2011
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63868-363)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63868-363)

Revised: 10/2013
 
CHAIN DRUG MARKETING ASSOCIATION INC

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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