FDA.reportPublic FDA data

Topcare pain and fever

Manufacturer
Topco Associates LLC
Effective date
2024-07-03
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:15:19

Label at a glance#

ProductTopcare 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. If possible, use weight to dose; otherwise, use age. • push air out of syringe. Insert syringe tip into bottle opening. • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push...

Storage and handling

• store at 20-25°C (68-77°F) • do not use if printed bottle wrap 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

  • new symptoms occur
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • 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. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into bottle opening.
  • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
  • pull yellow part of syringe until it reaches and stays at the correct dose
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance

Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

* or as directed by a doctor

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

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)
  • do not use if printed bottle wrap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, calcium sulfate, carrageenan, FD&C red #40, 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

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare® health

COMPARE TO INFANTS’ TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT

infants’ Pain & Fever

ORAL SUSPENSION

ACETAMINOPHEN, 160 mg per 5 mL

PAIN RELIEVER • FEVER REDUCER

FREE FROM:

• Aspirin

• Ibuprofen

• Alcohol

• Parabens

Pediatrician Preferred Dosing System

Use only with enclosed syringe.

See side panel for more information.

CHERRY FLAVOR

1 FL OZ (30 mL)

For Children

Infants' Pain & Fever Carton Image
Infants' Pain & Fever Carton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN8
307668acetaminophen 32 MG/ML Oral SuspensionSCD8
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY8
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY8
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY8
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY8
307668APAP 32 MG/ML Oral SuspensionSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-161-10Topcare pain and fever1 in 1 CARTONSUSPENSION18
36800-161-10Topcare pain and fever30 mL in 1 BOTTLESUSPENSION308
36800-161-16Topcare pain and fever1 in 1 CARTONSUSPENSION18
36800-161-16Topcare pain and fever59 mL in 1 BOTTLESUSPENSION598

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-161TOPCARE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC]8Current NDC, Legacy NDC, 4 package rows20240716_950b16d5-65db-402d-8ec6-eec9e1e174dd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D4
ACETAMINOPHENACTIVE MOIETY362O9ITL9D4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV84
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB5054
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3114
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJ4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU4
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6X4
SORBITOLINACTIVE INGREDIENT506T60A25R4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-16136800-161-10, 36800-161-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CALCIUM SULFATE, UNSPECIFIED FORMWAT0DDB505IACT
CARRAGEENAN5C69YCD2YJIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
HIGH FRUCTOSE CORN SYRUPXY6UN3QB6SIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL SOLUTION8KW3E207O2IACT
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 1 · 57 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
18 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
18 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
6 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
18 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
18 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
18 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
6 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
18 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
6 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
18 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XGRANULE / ORAL1 mgExact identifier — unii+route
6 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
18 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET / ORAL2734 mgExact identifier — unii+route
18 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ORAL1080 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, EXTENDED RELEASE / ORAL235 mgExact identifier — unii+route
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE / ORAL141.5 mgExact identifier — unii+route
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, TRIBASICSODIUM PHOSPHATE, TRIBASICA752Q30A6XPOWDER, FOR SUSPENSION / ORAL650 mgExact identifier — unii+route
6 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505CAPSULE, EXTENDED RELEASE / ORAL1.66 mgExact identifier — unii+route
18 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RSUSPENSION / ORAL45000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARRAGEENANCARRAGEENAN5C69YCD2YJSUSPENSION / ORAL6 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION / ORAL320 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, DELAYED RELEASE / ORAL127 mgExact identifier — unii+route
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
18 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSUSPENSION / ORAL400 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CALCIUM SULFATECALCIUM SULFATEWAT0DDB505TABLET, COATED / ORAL170 mgExact identifier — unii+route
18 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii+route+dosage form
3 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SUSPENSION / ORAL12 mgExact identifier — unii+route+dosage form
3 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 pain and feverACETAMINOPHENTopco Associates LLC950b16d5-65db-402d-8ec6-eec9e1e174dd2024-07-03WarningsExact identifier
ndc (package): 36800-161-16
ndc (package): 36800-161-10
ndc (product): 36800-161
ndc11 (package): 36800016116
ndc11 (package): 36800016110
spl id: 379dcaf6-995b-4e66-b09b-d0ddf0d4e571
spl set id: 950b16d5-65db-402d-8ec6-eec9e1e174dd

Reported adverse events (FAERS/openFDA)#

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