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Childrens Allergy by Chain Drug Consortium, LLC

Medically reviewed on Feb 28, 2018

Dosage form: liquid
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 12.5mg in 5mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-823

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.

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.

CHILDRENS ALLERGY 
diphenhydramine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-823
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
FD&C RED NO. 40 
GLYCERIN 
POLOXAMER 407 
WATER 
SODIUM BENZOATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SUCROSE 
Packaging
#Item CodePackage Description
1NDC:68016-823-54118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33609/11/2012
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIOperations
AptaPharma Inc.790523323manufacture(68016-823)

 
Chain Drug Consortium, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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