Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:
- headache
- sore throat
- the common cold
- toothache
- flu
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.

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.

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

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.

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

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
topcare@topco.com
www.topcarebrand.com

TopCare 44-450

CHILDRENS PAIN AND FEVER
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-450
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
D&C RED NO. 30 ALUMINUM LAKE (UNII: GE75M6YV5W)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color	pink	Score	2 pieces
Shape	ROUND	Size	16mm
Flavor	BUBBLE GUM	Imprint Code	44;450
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-450-08	1 in 1 CARTON	02/15/2019
1		24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M013	02/15/2019

Labeler - Topco Associates, LLC (006935977)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(36800-450)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(36800-450) , pack(36800-450)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(36800-450)

Topcare 44-450