CHILDRENS ALLERGY- diphenhydramine hydrochloride liquid 
Chain Drug Consortium, LLC

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Active ingredient

Drug Facts  

Active ingredient  
(in each 5 mL teaspoon)

Diphenhydramine HCL 12.5 mg

Purpose

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

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

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 Ask a doctor or pharmacist before use

Ask a doctor before use if the child has

•    glaucoma
•    a breathing problem such as chronic bronchitis

Ask a doctor or pharmacist before if the child is

taking sedatives or tranquilizers

When using this product

When using this product

•    marked drowsiness may occur
•    excitability may occur, especially in children
•    sedatives and tranquilizers may increase drowsiness

Directions

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

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

Inactive ingredients

Citric acid, D and C Red # 40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium chloride, sodium citrate, sucrose

Questions or comments?

Questions or comments?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

NDC 68016-0823-54

*COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY LIQUID

PREMIER VALUE ®

CHILDREN’S ALLERGY

DIPHENHYDRAMINE
HYDROCHLORIDE
ANTIHISTAMINE

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

Alcohol-Free
Cherry Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

DISTRIBUTED BY:
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431

BX-005

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

*This product is not manufactured or distributed by McNeil-PPC, Inc. distributer of Benadryl® Allergy Liquid.

AptaPharmaPV Childrens Allergy Label

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AptaPharmaPV Childrens Allergy Label

CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-823
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-823-54118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/11/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00909/11/2012
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(68016-823)

Revised: 12/2023
Document Id: 2c9d4607-6181-4524-87fd-15421729c8e0
Set id: d66ae916-36d3-462a-943e-4ad844dadcaa
Version: 3
Effective Time: 20231230
 
Chain Drug Consortium, LLC