Topcare 44-450

Topcare 44-450
SPL v9
SPL
SPL Set ID 87af092c-99e6-475d-81af-b9fd8fc337d7
Route
ORAL
Published
Effective Date 2025-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Citric Acid Monohydrate Crospovidone, Unspecified D&c Red No. 27 Aluminum Lake D&c Red No. 30 Aluminum Lake Dextrose Monohydrate Ethylcellulose, Unspecified Magnesium Stearate Mannitol High Density Polyethylene Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance
Imprint: 44;450 Shape: round Color: pink Size: 16 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-15

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses
  • temporarily relieves minor aches and pains due to:

    • headache
    • sore throat 
    • flu

    • toothache 
    • the common cold

  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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

  • skin reddening
  • blisters
  • rash

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (chewable tablets)*
Under 24

Under 2 Ask a doctor
24-35 2-3 1 tablet
36-47 4-5 1 1/2 tablets
48-59 6-8 2 tablets
60-71 9-10 2 1/2 tablets
72-95 11 3 tablets

*or as directed by a doctor

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.

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

  • avoid high humidity

  • see end flap for expiration date and lot number



Inactive Ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments?

1-888-423-0139

Principal Display Panel

+TopCare®

          health

NDC 36800-450-08

†COMPARE TO THE ACTIVE INGREDIENT IN

CHILDREN’S TYLENOL® CHEWABLES

children's 

Pain & Fever

ACETAMINOPHEN 160 mg,

CHEWABLE TABLETS

PAIN RELIEVER  •  FEVER REDUCER

• Ibuprofen Free   • Aspirin Free

Chew or crush tablets completely before swallowing.

BUBBLE

GUM

FLAVOR

24 CHEWABLE TABLETS

For Ages 2 to 11 Years

actual size

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING




QUALITY GUARANTEED

† This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Tylenol® Chewables.          50844     REV0424C45008

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO LNKA1024 QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

TopCare 44-450
Stop Use and Ask A Doctor If
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
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 Your Child Has

liver disease.

Active Ingredient (in Each Chewable Tablet)

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is 

taking the blood thinning drug warfarin.


Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:

    • headache
    • sore throat 
    • flu

    • toothache 
    • the common cold

  • temporarily reduces fever

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen

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

  • skin reddening
  • blisters
  • rash

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

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (chewable tablets)*
Under 24

Under 2 Ask a doctor
24-35 2-3 1 tablet
36-47 4-5 1 1/2 tablets
48-59 6-8 2 tablets
60-71 9-10 2 1/2 tablets
72-95 11 3 tablets

*or as directed by a doctor

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.

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

  • avoid high humidity

  • see end flap for expiration date and lot number



Inactive Ingredients (Inactive ingredients)

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel (Principal display panel)

+TopCare®

          health

NDC 36800-450-08

†COMPARE TO THE ACTIVE INGREDIENT IN

CHILDREN’S TYLENOL® CHEWABLES

children's 

Pain & Fever

ACETAMINOPHEN 160 mg,

CHEWABLE TABLETS

PAIN RELIEVER  •  FEVER REDUCER

• Ibuprofen Free   • Aspirin Free

Chew or crush tablets completely before swallowing.

BUBBLE

GUM

FLAVOR

24 CHEWABLE TABLETS

For Ages 2 to 11 Years

actual size

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER

CAP IS BROKEN OR MISSING




QUALITY GUARANTEED

† This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Tylenol® Chewables.          50844     REV0424C45008

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO LNKA1024 QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

TopCare 44-450
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • any new symptoms appear
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 Your Child Has (Ask a doctor before use if your child has)

liver disease.

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

Acetaminophen 160 mg

Ask A Doctor Or Pharmacist Before Use If Your Child Is  (Ask a doctor or pharmacist before use if your child is )

taking the blood thinning drug warfarin.


Advanced Ingredient Data


Raw Label Data

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