FDA.reportPublic FDA data

KOSHER MEDS Childrens Allergy Relief

Manufacturer
Mollec Inc
Effective date
2023-01-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:39:06

Label at a glance#

ProductKOSHER MEDS Childrens Allergy Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 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

Diphenhydramine HCI 12.5mg (in each 5 mL = 1 teaspoonful)

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

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • glaucoma
  • a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82179-00382179-003-04

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
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GLYCERINPDC6A3C0OXIACT
POLOXAMER 407TUF2IVW3M2IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SUCROSEC151H8M554IACT
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
18843f05-41f5-23f1-e063-6294a90aed409172dad6-e173-461c-9518-d113a33df9162024-05-15WarningsExact identifier
spl set id: 9172dad6-e173-461c-9518-d113a33df916

Reported adverse events (FAERS/openFDA)#

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