ADWE DYE-FREE CHILDRENS ALLERGY- diphenhydramine hydrochloride syrup 
RARITAN PHARMACEUTICALS 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 (in each 5 mL)

Diphenhydramine HCl USP 12.5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Warnings

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if the child has

a breathing problem such as chronic bronchitis
glaucoma

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

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

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

find right dose on chart below
take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
mL = milliliter

Age (yr)

Dose (mL)

children under 2 years

do not use

children 2 to 5 years

do not use unless directed by a doctor

children 6 to 11 years

5 mL to 10 mL

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

Other information

each 5 mL contains: sodium 3 mg
store at room temperature)
protect from sunlight
see bottom panel for lot number and expiration date
contains low sodium

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, flavors, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose.

PRINCIPAL DISPLAY PANEL

NDC 68163-710-08

Compare to active ingredient in Children'sBenadryl® Dye-Free*

Children’s Allergy Relief

Antihistamine

Diphenhydramine HCl

For Relief Of:

Runny nose
sneezing
itchy, watery eyes
Itchy Throat or Nose
 
Natural Cherry Flavor

8 fl oz (236 mL)

Manufactured for:

Adwe Laboratories

1274th 49 Street

Brooklyn, NY 11219

*This product is not manufactured or distributed by Johnson & Johnson, owner of the registered trademark Children’s Benadryl® Dye –Free.

 
ADWE dye-free childrens allergy
ADWE DYE-FREE CHILDRENS ALLERGY 
diphenhydramine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68163-710
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, UNSPECIFIED (UNII: K679OBS311)  
glycerin (UNII: PDC6A3C0OX)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitol (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorWHITE (Clear, colorless) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68163-710-081 in 1 CARTON11/22/2021
1236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/22/2021
Labeler - RARITAN PHARMACEUTICALS INC (127602287)

Revised: 8/2023
Document Id: bf8be390-9745-4ac3-868a-126c1fd8feac
Set id: ea3a51af-3025-497f-8cd7-e99391b0d06f
Version: 3
Effective Time: 20230816
 
RARITAN PHARMACEUTICALS INC