ASPIRIN- aspirin tablet, coated 
TOP CARE (Topco Associates LLC)

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.

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DRUG FACTS

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Purpose

Pain reliever 

Uses

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:  

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you:

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

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

  • an allergic reaction occurs. Seek medical help right away
  • 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 
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • ringing in the ears or loss of hearing occurs
  • new symptoms occur

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

Other information

Inactive ingredients

D&C yellow #10, FD&C yellow #6, methacrylic acid copolymer, microcrystalline cellulose, pregelatinized starch (corn), silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triethyl citrate


Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

COMPARE TO BAYER® LOW DOSE ASPIRIN ACTIVE INGREDIENT±

LOW DOSE

ASPIRIN REGIMEN†

Aspirin 81 mg

PAIN RELIEVER (NSAID)

Safety-Coated††

TABLETS

††Talk to your doctor or other healthcare provider before using this product for your heart. Aspirin is not right for everyone

††Coating helps protect against stomach upset

†This product is not manufactured or distributed by Bayer HealthCare LLC, distributor of Bayer® Low Dose Aspirin.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60007

topcare@topcare.com

Product Label

Aspirin 81 mg (NSAID)* *nonsteroidal anti-inflammatory drug

TOPCARE HEALTH Aspirin 81 mg

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-968
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code E
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-968-121 in 1 BOX04/01/2020
1120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:36800-968-501 in 1 CARTON04/01/2020
2500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:36800-968-05500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/01/2020
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 11/2022
Document Id: a84f40e2-1f7e-4c09-ac2c-24eefb36bce0
Set id: d3df90be-9037-44b2-bf48-540d68a033b2
Version: 6
Effective Time: 20221128
 
TOP CARE (Topco Associates LLC)