QUALITY CHOICE CHILDRENS ALLERGY RELIEF DYE FREE- diphenhydramine hydrochloride solution

QUALITY CHOICE by

Drug Labeling and Warnings

QUALITY CHOICE by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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 throat or Nose

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 istaking 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 at 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
• see bottom panel for lot number and expiration date
• protect from light
• contains low sodium

Inactive ingredients

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

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL

*Compare to the Active Ingredient in Children'sBenadryl ®Dye-Free

NDC: 83324-339-04

Children’s Allergy Relief

Dye-Free

Diphenhydramine HCl ǀ Antihistamine
Oral solution

For Relief of:

1. Runny Nose,
2. Itchy Throat or Nose
3. Sneezing and
4. Itchy, Watery Eyes

Sugar-Free

Natural Cherry Flavor

4 FL. OZ. (118 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED INNER SEAL UNDER CAP IS TORN OR MISSING

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

IMPORTANT:Keep this carton for the future reference on full labeling.

Distributed by: CDMA, INC,

Novi, MI 48375

www.qualitychoice.com

Questions: 800-935-2362

INGREDIENTS AND APPEARANCE

QUALITY CHOICE   CHILDRENS ALLERGY RELIEF DYE FREE
diphenhydramine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83324-339
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 (Natural)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83324-339-04	1 in 1 CARTON	08/01/2025
1		118 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 Drug	M012	08/01/2025

Labeler - QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) (011920774)