CHILDRENS ALLERGY- diphenhydramine hydrochloride solution 
ATLANTIC BIOLOGICALS CORP.

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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Drug Facts

Active ingredient [in each 5 mL]

Diphenhydramine HCl, USP 12.5 mg

Purpose

Antihistamine

Uses

Warnings

Do not use

Ask a doctor before use if the child has

Ask a doctor or pharmacist before use if you

are taking sedatives or tranquilizers

When using this product

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions


Age (yr)
Dose (mL)
children under 6 years of age
ask a doctor
children 6 years to under 12 years of age
5 mL to 10 mL

Attention: Use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

Inactive ingredients

anhydrous citric acid, carboxymethyl cellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments? 1-855-274-4122

Distributed ByATLANTIC BIOLOGICALS CORP. 

20101 N.E 16TH PLACE 

MIAMI, FL 33179

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL

NDC 17856-0361-01

Compare to
Children's Benadryl®
active ingredient*

Children's
ALLERGY
Antihistamine
diphenhydramine hydrochloride
25mg/10 mL oral solution 
liquid medication

Relieves:

Sugar & Alcohol Free
Dye-FreeBubble Gum Flavored


image 1

NDC 17856-0361-02

Compare to
Children's Benadryl®
active ingredient*

Children's
ALLERGY

Antihistamine

diphenhydramine hydrochloride
12.5mg/5mL oral solution
liquid medication

Relieves:

Runny Nose
Sneezing
Itchy, Watery Eyes
Itchy Throat
Sugar & Alcohol Free

Dye-Free
Bubble Gum Flavored

image 2

CHILDRENS ALLERGY 
diphenhydramine hydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17856-0361(NDC:46122-361)
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColorWHITE (Colorless) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17856-0361-172 in 1 BOX, UNIT-DOSE01/20/2021
110 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2NDC:17856-0361-272 in 1 BOX, UNIT-DOSE01/20/2021
25 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34105/20/2016
Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
Establishment
NameAddressID/FEIBusiness Operations
ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0361) , repack(17856-0361)

Revised: 1/2021
Document Id: 77d5678c-87ee-4143-a1ae-c2b31b3e547e
Set id: ffd0a29f-370d-4cb1-9b1f-bbcd43f3fc61
Version: 2
Effective Time: 20210120
 
ATLANTIC BIOLOGICALS CORP.