FDA.reportPublic FDA data

Dye Free Allergy

Manufacturer
QUALITY CHOICE (Chain Drug Marketing Association)
Effective date
2024-04-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:11:19

Label at a glance#

ProductDye Free Allergy childrens
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than 6 doses in 24 hours take every 4 to 6 hours, or as directed by a doctor measure only with dosing cup provided. Do not use any other dosing device.  mL = milliliter keep dosing cup with product  find the right dose on the chart below  age (yr)  dose (mL)  children 6 to 11 years 5 mL to 10 mL  children 2 to 5 years  do not use unless directed by a doctor  children under 2 years do not use

Storage and handling

each 5 mL contains : sodium 8 mg store between  20-25°C (68-77°F). Do not refrigerate. Protect from light. Store in outer carton until contents are used.

Label contents#

Full prescribing information#

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 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:

  • sneezing ​
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if the child has

OTC - ASK DOCTOR SECTION

  • a breathing problem such as chronic bronchitis
  • glaucoma
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if the child is

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than 6 doses in 24 hours
  • take every 4 to 6 hours, or as directed by a doctor
  • measure only with dosing cup provided. Do not use any other dosing device. 
  • mL = milliliter
  • keep dosing cup with product 
  • find the right dose on the chart below
 age (yr) dose (mL)
 children 6 to 11 years5 mL to 10 mL
 children 2 to 5 years do not use unless directed by a doctor
 children under 2 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each 5 mL contains: sodium 8 mg
  • store between  20-25°C (68-77°F). Do not refrigerate.
  • Protect from light. Store in outer carton until contents are used.

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, carboxymethycellulose sodium, flavor, glycerin, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

 Call 1-248-449-9300 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredient in Children's Benadryl® Allergy

Dye-Free

Children's

Allergy

Antihistamine

Diphenhydramine Hydrochloride 12.5mg / 5 mL Oral Solution

Liquid Medication

Relieves

Runny Nose | Sneezing |

Itchy, Watery Eyes | Itchy Throat

For Ages 6 to 11 Years

Alcohol-Free

Dye-Free

Bubble Gum Flavored

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributors of Benadryl® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc,©

43157 W.Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY CHOICE Dye-Free Children's Allergy
QUALITY CHOICE Dye-Free Children's Allergy

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN6
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD6
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY6
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY6
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY6

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
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-128-042023-04-27C16284748780-1f386c649-c82a-0266-e053-dadaa90a7c1aDrug Facts
63868-128-042023-01-30C16284748780-1f386c649-c82a-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-128-04Dye Free Allergychildrens1 in 1 BOXLIQUID16
63868-128-04Dye Free Allergychildrens118 mL in 1 BOTTLE, PLASTICLIQUID1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-128DYE FREE ALLERGY CHILDRENS (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]6Current NDC, Legacy NDC, 2 package rows20240423_f1a33c2f-2330-43f3-8026-de21808aec66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-128-04ML - Milliliter63868-128e5564ccc-c883-4a9d-bd1f-8afcef5e464b12022-08-04

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
63868-12863868-128-04

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT

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
Dye Free Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)f1a33c2f-2330-43f3-8026-de21808aec662024-04-22WarningsExact identifier
ndc (package): 63868-128-04
ndc (product): 63868-128
ndc11 (package): 63868012804
spl id: 2662f169-3db7-4eee-ba26-e5985af1bea6
spl set id: f1a33c2f-2330-43f3-8026-de21808aec66

Reported adverse events (FAERS/openFDA)#

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