FDA.reportPublic FDA data

Pain and Fever

Manufacturer
KinderFarms, LLC
Effective date
2024-04-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:10:56

Label at a glance#

ProductPain and Fever Childrens
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

store between 20-25ºC (68-77ºF) do not refrigerate see bottom panel for lot number and expiration date

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

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 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.

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

  • store between 20-25ºC (68-77ºF)
  • do not refrigerate
  • see bottom panel for lot number and expiration date

Inactive ingredient

INACTIVE INGREDIENT SECTION

Organic agave syrup, non-GMO citric acid, organic natural flavors, purified water

Questions?

OTC - QUESTIONS SECTION

Call 424-235-0355

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KIDS' PAIN & FEVER Ages 2 to 11 yrs

Acetaminophen

160 mg per 5 mL

Pain Reliever | Fever Reducer

Oral Suspension

Organic Cherry Flavor

NO COMMON ALLERGENS.

NO DYES OR PARABENS.

FL OZ (mL)

DOSING CUP INCLUDED

TAMPER EVIDENT: BOTTLE IS SAFETY SEALED WITH A PERFORATED BAND AROUND  BOTTLE. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

Keep outer carton for complete warnings and product information.

DISTRIBUTED BY: KinderFarms®

Redondo Beach, CA 90277 USA

kinderfarms.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KINDERMED Kids Pain & Fever Cherry Flavor
KINDERMED Kids Pain & Fever Cherry Flavor

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82673-097-04Pain and FeverChildrens118 mL in 1 BOTTLE, PLASTICSUSPENSION1183
82673-097-04Pain and FeverChildrens1 in 1 BOXSUSPENSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82673-097PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [KINDERFARMS, LLC]3Legacy NDC, 2 package rows20240411_f33db02a-58f4-41a5-8f1f-4ec64d17f5a1.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82673-09782673-097-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
AGAVE TEQUILANA JUICEGVG8G0207OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT

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
Pain and Fever ChildrensACETAMINOPHENKinderFarms, LLCf33db02a-58f4-41a5-8f1f-4ec64d17f5a12024-04-10WarningsExact identifier
ndc (package): 82673-097-04
ndc (product): 82673-097
ndc11 (package): 82673009704
spl id: 52688f1c-e600-4bc0-95ee-24086710e70e
spl set id: f33db02a-58f4-41a5-8f1f-4ec64d17f5a1

Reported adverse events (FAERS/openFDA)#

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