FDA.reportPublic FDA data

QUALITY CHOICE

Manufacturer
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Effective date
2025-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:11:29

Label at a glance#

ProductQUALITY CHOICE Childrens Allergy Relief DYE FREE
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and 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

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl USP 12.5 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use

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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the child has

  • a breathing problem such as chronic bronchitis
  • glaucoma

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

Quality Choice Childrens Allergy Relief Dye Free 4 Fl Oz
Quality Choice Childrens Allergy Relief Dye Free 4 Fl Oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN1
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD1
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY1
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-339-04QUALITY CHOICEChildrens Allergy Relief DYE FREE1 in 1 CARTONSOLUTION11
83324-339-04QUALITY CHOICEChildrens Allergy Relief DYE FREE118 mL in 1 BOTTLE, PLASTICSOLUTION1181

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-33983324-339-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CITRATEEE90ONI6FFIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICE Childrens Allergy Relief DYE FREEDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)644f39d8-7cd6-43dd-9265-546d01d32e8c2025-08-22WarningsExact identifier
ndc (package): 83324-339-04
ndc (product): 83324-339
ndc11 (package): 83324033904
spl id: 3cf1c37f-5278-d410-e063-6394a90a4132
spl set id: 644f39d8-7cd6-43dd-9265-546d01d32e8c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.