KOSHER MEDS CHILDRENS ALLERGY RELIEF- diphenhydramine hcl solution

Kosher Meds Childrens Allergy Relief by

Drug Labeling and Warnings

Kosher Meds Childrens Allergy Relief by is a Otc medication manufactured, distributed, or labeled by Mollec Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

(in each 5 mL teaspoonful)
Diphenhydramine HCl 12.5mg

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 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.

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

KOSHER MEDS CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82179-004
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82179-004-04	1 in 1 CARTON	04/18/2024
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	04/18/2024

Labeler - Mollec Inc (040088196)