Topcare 44-645

Topcare 44-645
SPL v7
SPL
SPL Set ID 56c125de-fabf-41fa-88a4-760d2793f202
Route
ORAL
Published
Effective Date 2025-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (81 mg)
Inactive Ingredients
Silicon Dioxide Starch, Corn Fd&c Red No. 40 Fd&c Yellow No. 6 Hypromellose, Unspecified Methacrylic Acid Microcrystalline Cellulose Polydextrose Polyethylene Glycol, Unspecified Shellac Dimethicone Water Sodium Bicarbonate Sodium Lauryl Sulfate Talc Titanium Dioxide Triacetin Triethyl Citrate

Identifiers & Packaging

Pill Appearance
Imprint: L Shape: round Color: pink Size: 6 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-19

Description

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

Purpose

Pain reliever


Medication Information

Purpose

Pain reliever

Description

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

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

  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
Directions
  • do not take more than directed

  • 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

Do Not Use

if you have ever had an allergic reaction to any other pain reliever/fever reducer



Other Information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients

colloidal anhydrous silica, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments?

1-888-423-0139

Principal Display Panel

NDC 36800-545-60

TopCare

health®

COMPARE TO THE ACTIVE INGREDIENT

IN ST. JOSEPH® LOW DOSE ASPIRIN†

LOW DOSE   ♥   ASPIRIN REGIMEN**

Aspirin 81 mg

PAIN RELIEVER (NSAID)



Safety Coated

**Talk to your doctor or other healthcare provider

before using this product for your heart.

actual size

180 ENTERIC COATED TABLETS

†This product is not manufactured or distributed by Foundation

Consumer Healthcare, LLC, owner of the registered trademark

St. Joseph® Low Dose Aspirin.

50844 REV1024B64560

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO LNKA0125

QUESTIONS?

1-888-423-0139

[email protected]

www.topcarebrand.com

This TopCare® product is laboratory

tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Topcare 44-645
Ask A Doctor Before Use If
  • you are taking a diuretic

  • 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

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:

    • vomit blood
    • have bloody or black stools
    • feel faint
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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.

Active Ingredient (in Each Tablet)

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Structured Label Content

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Purpose

Pain reliever

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

  • take more or for a longer time than directed
  • take a blood thinning (anticoagulant) or steroid drug
  • have had stomach ulcers or bleeding problems
  • have 3 or more alcoholic drinks every day while using this product
  • are age 60 or older
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
Directions
  • do not take more than directed

  • 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

Do Not Use (Do not use)

if you have ever had an allergic reaction to any other pain reliever/fever reducer



Other Information (Other information)
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
Inactive Ingredients (Inactive ingredients)

colloidal anhydrous silica, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel

NDC 36800-545-60

TopCare

health®

COMPARE TO THE ACTIVE INGREDIENT

IN ST. JOSEPH® LOW DOSE ASPIRIN†

LOW DOSE   ♥   ASPIRIN REGIMEN**

Aspirin 81 mg

PAIN RELIEVER (NSAID)



Safety Coated

**Talk to your doctor or other healthcare provider

before using this product for your heart.

actual size

180 ENTERIC COATED TABLETS

†This product is not manufactured or distributed by Foundation

Consumer Healthcare, LLC, owner of the registered trademark

St. Joseph® Low Dose Aspirin.

50844 REV1024B64560

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ITASCA, IL 60143

©TOPCO LNKA0125

QUESTIONS?

1-888-423-0139

[email protected]

www.topcarebrand.com

This TopCare® product is laboratory

tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Topcare 44-645
Ask A Doctor Before Use If (Ask a doctor before use if)
  • you are taking a diuretic

  • 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

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:

    • vomit blood
    • have bloody or black stools
    • feel faint
    • have stomach pain that does not get better
  • ringing in the ears or a loss of hearing occurs
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin 81 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

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

All Sections (JSON)