ADWE DYE-FREE CHILDRENS ALLERGY- diphenhydramine hydrochloride syrup

ADWE dye-free childrens allergy by

Drug Labeling and Warnings

ADWE dye-free childrens allergy by is a Otc medication manufactured, distributed, or labeled by RARITAN PHARMACEUTICALS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

INGREDIENTS AND APPEARANCE

ADWE DYE-FREE CHILDRENS ALLERGY 
diphenhydramine hydrochloride syrup

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68163-710
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Diphenhydramine hydrochloride (UNII: TC2D6JAD40) (diphenhydramine - UNII:8GTS82S83M)	Diphenhydramine hydrochloride	12.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (Clear, colorless)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68163-710-08	1 in 1 CARTON	11/22/2021
1		236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	11/22/2021

Labeler - RARITAN PHARMACEUTICALS INC (127602287)