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Chewable Aspirin Low Dose by CHAIN DRUG MARKETING ASSOCIATION INC

Medically reviewed on Apr 24, 2018

Dosage form: tablet
Ingredients: ASPIRIN 81mg
Labeler: CHAIN DRUG MARKETING ASSOCIATION INC
NDC Code: 63868-029

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 44-397

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:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • 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 a blood thinning (anticoagulant) or steroid drug
  • 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 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

cherry flavor, corn starch, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates, sodium saccharin 

Principal Display Panel

QC®
QUALITY
CHOICE

NDC 63868-029-36

Compare to the active ingredient
in BAYER® CHEWABLE
LOW DOSE ASPIRIN

Low Dose
Chewable Aspirin

Aspirin 81 mg

Pain Reliever (NSAID)
Chewable | Aspirin Regimen

Cherry
Flavor

36 Tablets

Actual Size

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

100% QC
SATISFACTION
GUARANTEED

Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300

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

50844           ORG061339707

Quality Choice 44-397

CHEWABLE ASPIRIN  LOW DOSE
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-029
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C RED NO. 27 
D&C RED NO. 30 
DEXTRATES 
SACCHARIN SODIUM 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorCHERRYImprint Code44;397
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-029-361 BOTTLE in 1 CARTON
136 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34309/04/2001
Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(63868-029)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(63868-029)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(63868-029)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(63868-029)

 
CHAIN DRUG MARKETING ASSOCIATION INC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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