KOSHER MEDS Childrens Allergy Relief by Mollec Inc

Drug Details [pdf]

KOSHER MEDS CHILDRENS ALLERGY RELIEF- diphenhydramine liquid
Mollec Inc

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Active Ingredient

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

Purpose

Antihistamine

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

Warnings

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 is

taking 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

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

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

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?

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

Product label

image description

KOSHER MEDS CHILDRENS ALLERGY RELIEF
diphenhydramine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82179-003
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 82179-003-04	1 in 1 CARTON	01/18/2023	04/01/2024
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	01/18/2023	04/01/2024

Labeler - Mollec Inc (040088196)

Revised: 5/2024

Document Id: 18843f05-41f5-23f1-e063-6294a90aed40

Set id: 9172dad6-e173-461c-9518-d113a33df916

Version: 4

Effective Time: 20240515

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