FDA.reportPublic FDA data

Childrens Pain and Fever

Manufacturer
TOPCO ASSOCIATES LLC | LNK International, Inc.
Effective date
2025-10-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:40:32

Label at a glance#

ProductChildrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using mL = milliliter only use the dose cup provided find the right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL)* Under 24 Under 2 Ask a doctor ...

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • headache
    • toothache
    • sore throat
    • flu
    • the common cold
  • temporarily reduces fever

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

liver disease.

Ask a doctor or pharmacist before use if your child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use
  • do not give more than directed
  • shake well before using
  • mL = milliliter
  • only use the dose cup provided
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (mL)*
Under 24Under 2Ask a doctor
24-352-35 mL
36-474-57.5 mL
48-596-810 mL
60-719-1012.5 mL
72-951115 mL

*or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

1-888-423-0139

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare®
health
COMPARE TO CHILDREN'S TYLENOL®
ORAL SUSPENSION ACTIVE INGREDIENT†
NDC 76162-079-36

children's
Pain & 
Fever

ACETAMINOPHEN,
160 mg per 5 mL
ORAL SUSPENSION
PAIN RELIEVER • FEVER REDUCER

• Aspirin Free
•Ibuprofen Free
•Alcohol Free

STRAWBERRY
FLAVOR

Ages 2
to
11 Years

4 FL OZ (118 mL)

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DIRECTIONS:
STEP 1.
Shake well
before using
STEP 2.
Remove child
protective
cap
STEP 3.
Pour your
child’s dose
into the
dosing cup

IMPORTANT:
Please see dosing chart or ask
a doctor for your child’s correct dose

†This product is not manufactured or distributed by Kenvue
Inc., owner of the registered trademark Children’s Tylenol®
Oral Suspension.
50844       REV0424A07936

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ITASCA, IL 60143
©TOPCO LNKA0525
QUESTIONS? 1-888-423-0139
topcare@topco.com
www.topcarebrand.com

Scan here for more
information or
call 1-888-423-0139

QUALITY GUARANTEED

TopCare 44-079TopCare 44-079

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN3
307668acetaminophen 32 MG/ML Oral SuspensionSCD3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY3
307668APAP 32 MG/ML Oral SuspensionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/4912ihtopcare-44-079-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-079-36Childrens Pain and Fever1 in 1 CARTONSUSPENSION13
76162-079-36Childrens Pain and Fever118 mL in 1 BOTTLE, PLASTICSUSPENSION1183

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-07976162-079-36

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-10full-release2026-06-01 00:24:17

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain and FeverACETAMINOPHENTOPCO ASSOCIATES LLCbbc367cc-6c79-498e-8fca-1347e6ea1a8c2025-10-22WarningsExact identifier
ndc (package): 76162-079-36
ndc (product): 76162-079
ndc11 (package): 76162007936
spl id: 05447f58-f56f-4a85-83d9-350d085e3de9
spl set id: bbc367cc-6c79-498e-8fca-1347e6ea1a8c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.