FDA.reportPublic FDA data

topcare childrens pain and fever

Manufacturer
Topco Associates LLC
Effective date
2025-12-13
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:23:40

Label at a glance#

Producttopcare childrens pain and fever
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

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

Dosage and administration

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more t...

Storage and handling

• each 5 mL contains: sodium 3 mg • store at 20-25 ° C (68-77 ° F) • do not use if printed neckband is broken or missing

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:

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

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.
  • if your child has ever had an allergic reaction to this product or any of its ingredients

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

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dose (see overdose warning)

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
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical 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 (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child’s dose into the dosing cup
  • 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 years

ask a doctor

24-35

2-3 years

5 mL

36-47

4-5 years

7.5 mL

48-59

6-8 years

10 mL

60-71

9-10 years

12.5 mL

72-95

11 years

15 mL

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
  • do not use if printed neckband is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate

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

children’s Pain & Fever

ORAL SUSPENSION

ACETAMINOPHEN, 160 mg per 5 mL

PAIN RELIEVER • FEVER REDUCER

FREE FROM:

• Aspirin • Ibuprofen

• Alcohol • Parabens

Ages 2 to 11 Years

GRAPE FLAVOR

4 FL OZ (118 mL)

130-88-childrens-pain-and-fever
130-88-childrens-pain-and-fever

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN11
307668acetaminophen 32 MG/ML Oral SuspensionSCD11
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY11
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY11
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY11
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY11
307668APAP 32 MG/ML Oral SuspensionSY11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codetopbrnds.com/4901t4image-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-202-00topcare childrens pain and fever236 mL in 1 BOTTLESUSPENSION23611
36800-202-00topcare childrens pain and fever1 in 1 CARTONSUSPENSION111
36800-202-26topcare childrens pain and fever1 in 1 CARTONSUSPENSION111
36800-202-26topcare childrens pain and fever118 mL in 1 BOTTLESUSPENSION11811
36800-202-28topcare childrens pain and fever148 mL in 1 BOTTLESUSPENSION14811
36800-202-28topcare childrens pain and fever1 in 1 CARTONSUSPENSION111
36800-202-34topcare childrens pain and fever118 mL in 1 BOTTLESUSPENSION11811
36800-202-34topcare childrens pain and fever2 in 1 CARTONSUSPENSION211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-202-26ML - Milliliter36800-20212f916a1-ae01-4778-9bd5-b224d4851d5012017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D3
ACETAMINOPHENACTIVE MOIETY362O9ITL9D3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV83
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB5053
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3113
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJ3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6X3
SORBITOLINACTIVE INGREDIENT506T60A25R3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-20236800-202-26, 36800-202-28, 36800-202-34, 36800-202-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CALCIUM SULFATE, UNSPECIFIED FORMWAT0DDB505IACT
CARRAGEENAN5C69YCD2YJIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SODIUM PHOSPHATE, TRIBASICA752Q30A6XIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 100 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION / ORAL0.13 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
30 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
30 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION / ORAL0.13 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
10 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSUSPENSION / ORAL1 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
30 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
30 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
30 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
30 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
10 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
30 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
30 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
30 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSUSPENSION / ORAL0.13 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
30 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
10 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
30 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
30 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
30 equally ranked IID candidates

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
topcare childrens pain and feverACETAMINOPHENTopco Associates LLC911492d5-e065-4b8f-b2dc-cb6a6678d0ae2025-12-13WarningsExact identifier
ndc (package): 36800-202-28
ndc (package): 36800-202-34
ndc (package): 36800-202-00
ndc (package): 36800-202-26
ndc (product): 36800-202
ndc11 (package): 36800020200
ndc11 (package): 36800020234
ndc11 (package): 36800020226
ndc11 (package): 36800020228
spl id: f5d35fd8-953d-48b6-a7a2-a79a9c3408db
spl set id: 911492d5-e065-4b8f-b2dc-cb6a6678d0ae

Reported adverse events (FAERS/openFDA)#

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