CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride liquid

Childrens Allergy Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Drug Facts

Active ingredient  
(in each 5 mL teaspoon)

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 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

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 and C Red # 33, FD and 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

SOUND BODY™
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL® ALLERGY LIQUID*

Relieves:  Sneezing, Runny Nose, Itchy Watery Eyes, Itchy Throat

Children’s
Allergy
Relief

Diphenhydramine HCL Oral Solution Antihistamine

Alcohol-free

Cherry Flavor

4 FL OZ (118 mL)

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

Manufactured by:
AptaPharma Inc.
1533 Union Ave.
Pennsauken, NJ 08110

V#5002632  ITEM#301

BX-034

LOT:
EXP:

res

INGREDIENTS AND APPEARANCE

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-301
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)
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: 76281-301-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/21/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/21/2013

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-301)