drug facts

drug facts
SPL v8
SPL
SPL Set ID d3df90be-9037-44b2-bf48-540d68a033b2
Route
oral
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
aspirin (81 mg)
Inactive Ingredients
sodium lauryl sulfate talc triethyl citrate d&c yellow no. 10 fd&c yellow no. 6 methacrylic acid - methyl methacrylate copolymer (1:1) cellulose, microcrystalline starch, corn silicon dioxide sodium bicarbonate stearic acid titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: E Shape: round Color: yellow Size: 7 mm Score: 1
Marketing Status
otc monograph drug completed Since 2020-04-01 Until 2028-04-28

Purpose

Pain reliever 

Description

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


Medication Information

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
  • 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
Active Ingredient

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
  • ask your doctor about other uses for safety coated 81 mg aspirin
Purpose

Pain reliever 

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: consult a doctor
Other Information
  • store between 15-30ºC (59-86ºF)
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



Description

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

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

[email protected]

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
Product Label
TOPCARE HEALTH Aspirin 81 mg
Questions Or Comments?

Call toll free 1-888-423-0139

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 
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.

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis 

Structured Label Content

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
  • 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
Active Ingredient (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug 

Uses
  • for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.
  • ask your doctor about other uses for safety coated 81 mg aspirin
Purpose

Pain reliever 

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: consult a doctor
Other Information (Other information)
  • store between 15-30ºC (59-86ºF)
Inactive Ingredients (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



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

[email protected]

Do Not Use (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
Product Label
TOPCARE HEALTH Aspirin 81 mg
Questions Or Comments? (Questions or comments?)

Call toll free 1-888-423-0139

Ask A Doctor Before Use If (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 
Stop Use and Ask A Doctor If (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, (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. (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.

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for

  • gout
  • diabetes
  • arthritis 

Advanced Ingredient Data


Raw Label Data

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