FDA.reportPublic FDA data

Childrens Allergy

Manufacturer
Genexa Inc.
Effective date
2025-02-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:56:14

Label at a glance#

ProductChildrens Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Storage and handling

Other information store between 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Diphenhydramine HCl 12.5 mg

OTC - PURPOSE SECTION

Purpose

Antihistamine

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

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 you have

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to enlargement of the prostate gland

OTC - ASK DOCTOR SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

OTC - WHEN USING SECTION

When using this product

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

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. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 doses in 24 hours
  • use only with enclosed dose cup. Do not use with any other dosing device.
adults and children 12 years of age and over10 - 20 mL
children 6 to under 12 years5 - 10 mL
children 2 to under 6 yearsdo not use unless directed by a doctor
children under 2 yearsdo not use

STORAGE AND HANDLING SECTION

Other information

store between 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic agave syrup, natural citric extract, purified water

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by

Johnson & Johnson Corp., owner of the registered

trademark Children's Benadryl® Allergy Liquid Cherry.

Bottle is safety sealed with a perforated band around bottle.

DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by: Genexa Inc.

Atlanta, GA 30318 | genexa.com

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients.

NDC 69676-0074-9

RECENT MAJOR CHANGES SECTION

Directions

take every 4 to 6 hours, or as directed by a doctor
do not take more than 6 doses in 24 hours
use only with enclosed dose cup. Do not use with any other dosing device.

adults and children 12 years of age and over 10 - 20 mL
children 6 to under 12 years 5 - 10 mL
children 2 to under 6 yearsdo not use unless directed by a doctor
children under 2 yearsdo not use

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's

Genexa®

MEDICINE MADE CLEAN

Ages 6+

Allergy

Diphenhydramine HCl Oral Solution

12.5 mg per 5 mL | Antihistamine

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

Runny Nose

Compareto active ingredient in Children’s
Benadryl® Allergy Liquid Cherry*

How we're different

Made without:

FD&C red no. 40,

sodium benzoate, sucrose & more!

Organic Agave Syrup Flavor

Alcohol Free

4 FL OZ (118 mL) Dosing cup included

100A_Allergy_Childrens_Carton_R-20220214100A_Allergy_Childrens_Carton_R-20220214

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN2
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD2
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY2
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY2

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
69676-0074-92025-02-26C16284748780-12cef2736-a29d-d83d-e063-dadaa90ab31fChildren's Allergy
69676-0074-92025-01-30C16284748780-12cef2736-a29d-d83d-e063-dadaa90ab31fChildren's Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0074-9Childrens Allergy1 in 1 CARTONSOLUTION12
69676-0074-9Childrens Allergy118 mL in 1 BOTTLE, PLASTICSOLUTION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69676-0074CHILDRENS ALLERGY (DIPHENHYDRAMINE HCL) SOLUTION [GENEXA INC.]2Current NDC, 2 package rows20250228_e880b8d7-61c3-41cc-e053-2995a90aaaeb.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-007469676-0074-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
AGAVE TEQUILANA JUICEGVG8G0207OIACT
WATER059QF0KO0RIACT
CITRUS FRUITXDK00Z8012IACT
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
Childrens AllergyDIPHENHYDRAMINE HCLGenexa Inc.e880b8d7-61c3-41cc-e053-2995a90aaaeb2025-02-20WarningsExact identifier
ndc (package): 69676-0074-9
ndc (product): 69676-0074
ndc11 (package): 69676007409
spl id: 2ea022ca-e2ee-3856-e063-6294a90a484f
spl set id: e880b8d7-61c3-41cc-e053-2995a90aaaeb

Reported adverse events (FAERS/openFDA)#

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