topcare 44-531

topcare 44-531
SPL v10
SPL
SPL Set ID 8b9e90da-98e2-4d8d-bf6e-54b0a8f8d101
Route
oral
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
starch, corn d&c red no. 27 aluminum lake d&c yellow no. 10 aluminum lake fd&c blue no. 1 aluminum lake polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified stearic acid sucralose talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;531 Shape: round Color: red Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2019-01-30 Until 2022-09-23
Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

Medication Information

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours

  • with other drugs containing acetaminophen

  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Active Ingredient

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains due to:

    • toothache
    • headache

    • the common cold
    • backache

    • muscular aches

    • minor pain of arthritis

    • premenstrual and menstrual cramps

  • temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions
  • do not take more than directed

  • adults and children 12 years and over

    • take 2 tablets every 6 hours while symptoms last

    • do not take more than 6 tablets in 24 hours, unless directed by a doctor

    • do not take for more than 10 days unless directed by a doctor

  • children under 12 years: ask a doctor

Other Information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive Ingredients

corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient

Description

Acetaminophen 500 mg

Principal Display Panel

+TopCare®

health

NDC 36800-991-15

COMPARE TO THE

ACTIVE INGREDIENT IN

EXTRA STRENGTH TYLENOL®†

EXTRA STRENGTH

Pain Relief

 ACETAMINOPHEN 500 mg

PAIN RELIEVER • FEVER REDUCER

Contains no aspirin • Coated tablets 

50 TABLETS

actual size

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

† This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Extra Strength Tylenol®.

50844      REV1123A53115

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

© TOPCO LNKA0124

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Scan here for more

information or call 1-888-423-0139

QUALITY GUARANTEED

This TopCare® product is laboratory

tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Topcare 44-531C
Do Not Use
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Questions Or Comments?

1-888-423-0139

Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • new symptoms occur

  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin.

Structured Label Content

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours

  • with other drugs containing acetaminophen

  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • blisters
  • rash
  • skin reddening

If a skin reaction occurs, stop use and seek medical help right away.

Active Ingredient (Active ingredient (in each tablet))

Acetaminophen 500 mg

Uses
  • temporarily relieves minor aches and pains due to:

    • toothache
    • headache

    • the common cold
    • backache

    • muscular aches

    • minor pain of arthritis

    • premenstrual and menstrual cramps

  • temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions
  • do not take more than directed

  • adults and children 12 years and over

    • take 2 tablets every 6 hours while symptoms last

    • do not take more than 6 tablets in 24 hours, unless directed by a doctor

    • do not take for more than 10 days unless directed by a doctor

  • children under 12 years: ask a doctor

Other Information (Other information)
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, D&C red #27 aluminum lake, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate*, stearic acid, sucralose, talc, titanium dioxide

*may contain this ingredient

Principal Display Panel (Principal display panel)

+TopCare®

health

NDC 36800-991-15

COMPARE TO THE

ACTIVE INGREDIENT IN

EXTRA STRENGTH TYLENOL®†

EXTRA STRENGTH

Pain Relief

 ACETAMINOPHEN 500 mg

PAIN RELIEVER • FEVER REDUCER

Contains no aspirin • Coated tablets 

50 TABLETS

actual size

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING

† This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Extra Strength Tylenol®.

50844      REV1123A53115

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ITASCA, IL 60143

© TOPCO LNKA0124

QUESTIONS? 1-888-423-0139

[email protected] www.topcarebrand.com

Scan here for more

information or call 1-888-423-0139

QUALITY GUARANTEED

This TopCare® product is laboratory

tested to guarantee its highest quality.

Your total satisfaction is guaranteed.

Topcare 44-531C
Do Not Use (Do not use)
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • new symptoms occur

  • redness or swelling is present

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

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

taking the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.069478 · Updated: 2026-03-14T23:09:16.713853