CHILDRENS PAIN AND FEVER- acetaminophen tablet, chewable 
Topco Associates, LLC

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TopCare 44-449

Active ingredient (in each chewable tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Warnings

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

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

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.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product

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.

When using this product

do not exceed recommended dosage.

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
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

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

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

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 CHILDREN’S
TYLENOL® ACTIVE INGREDIENT

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 Johnson & Johnson
Corporation, owner of the registered trademark Children’s Tylenol®.
50844      REV0522B44908

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007 ©TOPCO LNKA0521
QUESTIONS? 1-888-423-0139
topcare@topco.com www.topcarebrand.com
Visit here for more information: http://topbrnds.com/48ZZSG

TopCare 44-449

TopCare 44-449

CHILDRENS PAIN AND FEVER 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-449
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorpurpleScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code 44;449
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-449-081 in 1 CARTON02/15/2019
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01302/15/2019
Labeler - Topco Associates, LLC (006935977)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(36800-449)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(36800-449) , pack(36800-449)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(36800-449)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(36800-449)

Revised: 8/2023
Document Id: 667fc9e6-2b27-4bb9-a527-4f229bba7a25
Set id: 7f7b4377-9b40-4a12-808b-f1cd7d241b0d
Version: 8
Effective Time: 20230824
 
Topco Associates, LLC