FDA.reportPublic FDA data

Pain Relief Fever Reducer

Manufacturer
Ellywell, LLC
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:25:18

Label at a glance#

ProductPain Relief Fever Reducer children
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily reduces fever temporarily 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 take more than directed (see overdose warning) shake well before using mL= milliliter use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed...

Storage and handling

each 5 mL contains : sodium 5 mg store between 20-25ºC (68-77ºF) do not refrigerate

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

Warnings

WARNINGS SECTION

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. 

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

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 non-prescription). 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

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 dosage (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days

These could be signs of a serious condition.<</html>

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 take more than directed (see overdose warning)
  • shake well before using
  • mL= milliliter
  • use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor
  • find the right dose on chart below. If possible, use weight to dose, use age.
Weight (lb)Age (year)Dose (mL)*
 under 24under 2ask a doctor
 24-352-35 mL
 36-474-5 7.5 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

  • each 5 mL contains: sodium 5 mg
  • store between 20-25ºC (68-77ºF)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

disodium EDTA, disodium phosphate heptahydrate, flavors, glycerin, methylparaben, monobasic sodium phosphate monohydrate, purified water, sodium metabisulfite, sorbitol solution, stevia,xanthan gum

Questions or Comments?

OTC - QUESTIONS SECTION

Call 312-546-1905 M-F/ 9am-5pm / CST 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ellywell

Children's Pain Reliever & Fever Reducer

acetaminophen 160 mg per 5 mL

oral suspension

  • orange flavor
  • sweetener with stevia
  • dye-free
  • aspirin and ibuprofen free
  • alcohol-free
  • for ages 2-11 years

**compare to the active ingredient in Children's Tylenol® Oral Suspension

FL OZ (mL)

**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING

Distributed by: Ellywell Naperville, IL

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ELLYWELL Children's Pain Reliever & Fever Reducer
ELLYWELL Children's Pain Reliever & Fever Reducer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN6
307668acetaminophen 32 MG/ML Oral SuspensionSCD6
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY6
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY6
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY6
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY6
307668APAP 32 MG/ML Oral SuspensionSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80272-002-04Pain Relief Fever Reducerchildren1 in 1 BOXSUSPENSION16
80272-002-04Pain Relief Fever Reducerchildren118 mL in 1 BOTTLE, PLASTICSUSPENSION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80272-002PAIN RELIEF FEVER REDUCER CHILDREN (ACETAMINOPHEN) SUSPENSION [ELLYWELL, LLC]6Legacy NDC, 2 package rows20241016_92f26bb4-da58-4db4-83bc-aec1ebab2dbf.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80272-00280272-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
GLYCERINPDC6A3C0OXIACT
STEVIA LEAF6TC6NN0876IACT
SODIUM METABISULFITE4VON5FNS3CIACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

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
72ac9081-fc93-4348-adf9-93c435aaa5be92f26bb4-da58-4db4-83bc-aec1ebab2dbf2024-10-14WarningsExact identifier
spl id: 72ac9081-fc93-4348-adf9-93c435aaa5be
spl set id: 92f26bb4-da58-4db4-83bc-aec1ebab2dbf

Reported adverse events (FAERS/openFDA)#

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