FDA.reportPublic FDA data

Kosher Meds Childrens Allergy Relief

Manufacturer
Mollec Inc
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:12:36

Label at a glance#

ProductKosher Meds Childrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other respiratory allergies: sneezing itching of the nose or throat runny nose itchy watery eyes temporarily relieves these symptoms due to the common cold: sneezing runny nose

Dosage and administration

 if needed, take every 4-6 hours do not take more than 6 doses in 24 hours  Children under 4 years of age:  do not use  Children 4 to under 6 years of age:  do not use unless directed by a doctor  Children 6 to under 12 years of age:  1 to 2 teaspoonfuls (12.5 mg to 25 mg)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each 5 mL teaspoonful)
Diphenhydramine HCl 12.5mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other respiratory allergies:
  • sneezing
  • itching of the nose or throat
  • runny nose
  • itchy watery eyes
  • temporarily relieves these symptoms due to the common cold:
  • sneezing
  • runny nose

Warnings

WARNINGS SECTION

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy

Ask a doctor before use if the child has

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child istaking sedatives or tranquilizers

When using this product

  • marked drowsiness may occur
  • excitability may occur, especially in children
  • sedatives and tranquilizers may increase drowsiness

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  •  if needed, take every 4-6 hours
  • do not take more than 6 doses in 24 hours
 Children under 4 years of age: do not use
 Children 4 to under 6 years of age: do not use unless directed by a doctor
 Children 6 to under 12 years of age: 1 to 2 teaspoonfuls (12.5 mg to 25 mg)

Other Information

SPL UNCLASSIFIED SECTION

  • Keep carton for full directions for use
  • each teaspoonful contains: sodium 10 mg
  • store at 20° - 25° C (68° - 77° F)
  • dosage cup provided

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric acid, D&C Red # 33, FD&C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

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
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82179-004-04Kosher Meds Childrens Allergy Relief118 mL in 1 BOTTLESOLUTION1182
82179-004-04Kosher Meds Childrens Allergy Relief1 in 1 CARTONSOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82179-004KOSHER MEDS CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [MOLLEC INC]2Current NDC, 2 package rows20240517_42ad618b-d2e5-4c58-9407-386df4fe4004.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82179-00482179-004-04

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
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCROSEC151H8M554IACT
D&C RED NO. 339DBA0SBB0LIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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 Allergy ReliefDIPHENHYDRAMINE HCLMollec Inc42ad618b-d2e5-4c58-9407-386df4fe40042024-05-15WarningsExact identifier
ndc (package): 82179-004-04
ndc (product): 82179-004
ndc11 (package): 82179000404
spl id: 18844590-5a14-4d49-e063-6394a90ae0cf
spl set id: 42ad618b-d2e5-4c58-9407-386df4fe4004

Reported adverse events (FAERS/openFDA)#

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