FDA.reportPublic FDA data

Kids' Allergy Liquid

Manufacturer
Genexa Inc.
Effective date
2026-05-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:57:34

Label at a glance#

ProductKids Allergy
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 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
  • marked drowsiness may occur
  • use only with enclosed dose cup. Do not use with any other dosing device.
  • SHAKE WELL BEFORE EACH USE
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

agave syrup (organic), flavor (natural), purified water

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

SHAKE WELL BEFORE EACH USE

DO NOT use if perforated band around the bottle or seal under the cap is disturbed or missing.

Distributed by: Genexa Inc., Atlanta, GA 30324

genexa.com

NDC 69676-0039-9

Made in the USA with globally sourced ingredients

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
  • marked drowsiness may occur
  • use only with enclosed dose cup. Do not use with any other dosing device.
  • SHAKE WELL BEFORE EACH USE
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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa ®

CLEAN MEDICINE

Ages 6+

Kids' Allergy

Diphenhydramine HCl

Oral Solution

12.5 mg per 5 mL | Antihistamine

Sneezing

Itchy, Watery Eyes

Itchy Throat or Nose

Runny Nose

0% Artificial Additives, Dyes, Artificial Sweeteners, Common Allergens

Made with Real Agave

4 FL OZ (118 mL)

100A carton_R-20260318100A carton_R-20260318

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN7
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD7
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY7
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY7
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY7

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0039-9Kids Allergy118 mL in 1 BOTTLE, PLASTICLIQUID1187
69676-0039-9Kids Allergy1 in 1 CARTONLIQUID17

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-003969676-0039-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
AGAVE TEQUILANA JUICEGVG8G0207OIACT
WATER059QF0KO0RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62026-02-25monthly-update2026-06-03 17:56:47
52025-11-25monthly-update2026-06-03 17:40:48

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
Kids AllergyDIPHENHYDRAMINE HCLGenexa Inc.a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec42026-05-08WarningsExact identifier
ndc (package): 69676-0039-9
ndc (product): 69676-0039
ndc11 (package): 69676003909
spl id: 5158eb26-d61e-b74d-e063-6294a90a936c
spl set id: a7bc5f7c-eaeb-25d0-e053-2a95a90a9ec4

Reported adverse events (FAERS/openFDA)#

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