Medication Guide App

← See all Aspirin Enteric Coated brands

Aspirin Enteric Coated by CHAIN DRUG MARKETING ASSOCIATION INC

Dosage form: tablet, delayed release
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 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
  • asthma (wheezing)
  • facial swelling
  • shock

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
  • 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
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if
  • you have asthma
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • stomach bleeding warning applies to you

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

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
  • use by expiration date on package
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

Principal display panel

NDC 63868-363-36

QC®
QUALITY
CHOICE

Compare to the Active
Ingredient in Bayer®
Low Dose Aspirin

Enteric Coated
Aspirin 81mg
(NSAID)

Pain Reliever

Low Dose
Aspirin Regimen
Easy to Swallow

365 Tablets
(81 mg Each)

Actual Size

This product is not manufactured or distributed by Bayer HealthCare
LLC, owner of the registered trademark Bayer® Low Dose Aspirin.
50844            ORG061360051

SATISFACTION
GUARANTEED
100%

QC

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

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

Quality Choice 44-600

ASPIRIN  ENTERIC COATED
aspirin tablet, delayed release
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 
METHACRYLIC ACID 
POLYDEXTROSE 
TRIETHYL CITRATE 
POLYETHYLENE GLYCOLS 
SHELLAC 
Product Characteristics
ColorYELLOWScoreno score
ShapeROUNDSize7mm
FlavorImprint CodeL
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-363-201 BOTTLE, PLASTIC in 1 BOX
1120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
2NDC:63868-363-36365 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34305/01/2011
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: 03/2015
 
CHAIN DRUG MARKETING ASSOCIATION INC

← See all Aspirin Enteric Coated brands

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.

Hide
(web2)