CHILDRENS ALLERGY RELIEF- diphenhydramine hcl liquid

Childrens Allergy Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug FactsActive ingredient

Active ingredient

(in each 5 mL teaspoonful)

Diphenhydramine HCL 12.5 mg

Purpose

Antihistamine

Keep out of reach of children.

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

Uses

• temporarily relives 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 childrren
• sedatives and tranquilizers may increase drowsiness

Directions

• if needed, take every 4 to 6 hours
• do not take more than 6 doses in 24 hours

• Age (yr): Dose (mL or tsp)
• Children under 4 years: do not use
• Children 4 to under 6 years: do not use unless directed by a doctor
• Children 6 to under 12 years: 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 and C Red # 33 FD and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Marcs Childrens Allergy Relief Product Label

NDC: 68998-505-24

Compare to the active ingredient in children's Benadryl® allergy liquid*

Marcs

Children's

Allergy

Relief

Antihistamine

Diphenhydramine HCL

Oral Solution

Relieves:

Sneezing, Runny Nose,

Itchy Watery Eyes,

Itchy Throat

Alcohol-Free

CHERRY FLVOR

4 FL OZ (118 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

* This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of "Children's Benadryl Allergy Liquid."

Distributed By:

Marc Glassman, Inc.

West 130th Street

Cleveland, OH 44130

BX-044

Internal Label - LR-075  Lot:     Exp:

res

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenhydramine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-505
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (CHERRY)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-505-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/02/2014

Labeler - Marc Glassman, Inc. (094487477)