Topcare 44-449

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 Dextrose Monohydrate Ethylcellulose, Unspecified Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Mannitol High Density Polyethylene Stearic Acid Sucralose

Identifiers & Packaging

Pill Appearance

Imprint: 44;449 Shape: round Color: purple Size: 16 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-02-15

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, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments?

1-888-423-0139

Principal Display Panel

+TopCare®

health

NDC 36800-449-08

†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.

GRAPE

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

†This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Tylenol® Chewables.

50844 REV0424C44908

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO LNKA1224 QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

TopCare 44-449

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
any new symptoms appear
redness or swelling is present

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, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions Or Comments? (Questions or comments?)

1-888-423-0139

Principal Display Panel

+TopCare®

health

NDC 36800-449-08

†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.

GRAPE

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

†This product is not manufactured or distributed by

Kenvue Inc., owner of the registered trademark

Children’s Tylenol® Chewables.

50844 REV0424C44908

DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143

©TOPCO LNKA1224 QUESTIONS? 1-888-423-0139

[email protected]

www.topcarebrand.com

TopCare 44-449

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
any new symptoms appear
redness or swelling is present

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

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSPOVIDONE, UNSPECIFIED", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 27 ALUMINUM LAKE", "unii": "ZK64F7XSTX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 30", "unii": "2S42T2808B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DEXTROSE MONOHYDRATE", "unii": "LX22YL083G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLCELLULOSE, UNSPECIFIED", "unii": "7Z8S9VYZ4B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH DENSITY POLYETHYLENE", "unii": "UG00KM4WR7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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": "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, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose", "Questions or comments?": "1-888-423-0139", "Principal Display Panel": "+TopCare ® health NDC 36800-449-08 †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. GRAPE 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 †This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Children’s Tylenol® Chewables. 50844 REV0424C44908 DISTRIBUTED BY TOPCO ASSOCIATES LLC, ITASCA, IL 60143 ©TOPCO LNKA1224 QUESTIONS? 1-888-423-0139 topcare@topco.com www.topcarebrand.com TopCare 44-449", "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 any new symptoms appear redness or swelling is present", "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information