KOSHER MEDS Childrens Pain and Fever

Manufacturer
Mollec Inc
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:37

Label at a glance#

ProductKOSHER MEDS Childrens Pain and Fever
Active ingredientACETAMINOPHEN
Label structure15 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 shake well before using mL = milliliter; tsp = teaspoonful find right dose on chart below. If possible, use weight to dose; otherwise use age. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor. Dosing Chart Weight (lb) Age (yr) Do...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL = 1 teaspoonful)
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 is allergic to acetaminophen or any of the inactive ingredients in this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if your child hasliver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if your child istaking 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
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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
  • shake well before using
  • mL = milliliter; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose; otherwise use age.
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor.

Dosing Chart

Weight (lb)Age (yr)Dose (mL or tsp)*
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL  (1 tsp)
36-47 lbs4-5 years7.5 mL  (1 1⁄2 tsp)
48-59 lbs6-8 years

10 mL   (2 tsp)

60-71 lbs9-10 years12.5 mL  (2 1⁄2 tsp)
72-95 lbs11 years

15 mL  (3 tsp)

*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

SPL UNCLASSIFIED SECTION

  • Keep carton for full directions for use
  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN4
307668acetaminophen 32 MG/ML Oral SuspensionSCD4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY4
307668APAP 32 MG/ML Oral SuspensionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82179-002-04KOSHER MEDS Childrens Pain and Fever118 mL in 1 BOTTLESUSPENSION1184
82179-002-04KOSHER MEDS Childrens Pain and Fever1 in 1 CARTONSUSPENSION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82179-002KOSHER MEDS CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [MOLLEC INC]4Current NDC, 2 package rows20240517_4d01c9ee-26be-4cdd-b52d-7fa344c1933a.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82179-00282179-002-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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
KOSHER MEDS Childrens Pain and FeverACETAMINOPHENMollec Inc4d01c9ee-26be-4cdd-b52d-7fa344c1933a2024-05-15WarningsExact identifier
ndc (package): 82179-002-04
ndc (product): 82179-002
ndc11 (package): 82179000204
spl id: 1883ff2f-8602-0346-e063-6394a90a405d
spl set id: 4d01c9ee-26be-4cdd-b52d-7fa344c1933a

Reported adverse events (FAERS/openFDA)#

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