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Aspirin by QUALITY CHOICE (Chain Drug Marketing Association)

Medically reviewed on February 22, 2018

Dosage form: tablet, coated
Ingredients: ASPIRIN 81mg
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-354

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.

Drug Facts

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever 

Uses

Temporarily relieves minor aches and pains.

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
  • 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]
  • 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
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • ringing in the ears or a loss of hearing occurs

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 of age: do not use unless directed by a doctor 

Other information
  • store at controlled room temperature 20º-25ºC (68º-77ºF)

Inactive ingredients

anhydrous lactose, carnauba wax, colloidal silicon dioxide, croscarmellose sodium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake,  iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80,  simethicone, sodium hydroxide, sodium lauryl sulfate, talc, triethyl citrate

Questions or comments?

Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

​Principal Display Panel

†Compare to the active ingredient in St. Joseph® Low Dose Aspirin

Safety Coated**

Aspirin 81 mg

Pain Reliever (NSAID)

Small, Easy to Swallow

Safety coated

Aspirin Regimen≠

Tablets

†This product is not manufactured or distributed by St. Josephs Health Products, LLC, distributor of St. Joseph® Low Dose Aspirin.

**Coating helps protect against stomach upset

≠Talk to your doctor before starting an aspirin regimen. Aspirin is not right for everyone

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

KEEP OUTER CARTON FOR COMEPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Product Label

Quality Choice Safety Coated Aspirin 81 mg

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-354
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
FERRIC OXIDE YELLOW 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
CELLULOSE, MICROCRYSTALLINE 
POLYSORBATE 80 
DIMETHICONE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
TALC 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize7mm
FlavorImprint Codeheart
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-354-451 BOTTLE, PLASTIC in 1 BOX
145 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34307/31/2014
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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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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