CHILDRENS ALLERGY RELIEF- diphenhydramine hydrochloride liquid 
AptaPharma Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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:

AptaPharma ChildAllergyRelief Label

AptaPharma ChildAllergyRelief1 Label

res

CHILDRENS ALLERGY RELIEF 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76281-301
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorCHERRY (CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76281-301-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/21/2013
Labeler - AptaPharma Inc. (790523323)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(76281-301)

Revised: 10/2019
Document Id: 80d18641-4f89-4859-bdc0-ca7120be4d1c
Set id: ba3e2fd5-14d2-4fce-9de3-b0b9c1d2ee8f
Version: 2
Effective Time: 20191028
 
AptaPharma Inc.