FDA.reportPublic FDA data

Genexa Kids Sleepology

Manufacturer
Genexa Inc.
Effective date
2025-02-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:36:32

Label at a glance#

ProductGenexa Kids Sleepology
Active ingredientESCHSCHOLZIA CALIFORNICA, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, MATRICARIA CHAMOMILLA WHOLE, TRIBASIC CALCIUM PHOSPHATE, SCUTELLARIA LATERIFLORA TOP, MELISSA OFFICINALIS LEAF, PULSATILLA VULGARIS, ALFALFA
Label structure13 sections

Storage and handling

Other information store between 20°-25°C (68°-77°F) in a dry place out of direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Keep outer package for complete product information

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients‡**

Alfalfa 6X HPUS

Calcarea phosphorica 8X HPUS

Chamomilla 6X HPUS

Eschscholtzia californica 6X HPUS

Melissa officinalis 3X HPUS

Passiflora incarnata 6X HPUS

Pulsatilla 12X HPUS

Scutellaria lateriflora 3X HPUS

Valeriana officinalis 6X HPUS

‡ Organic

"HPUS" indicates that this ingredient is officially included in the Homoeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose

restless sleep

frequent waking

inability to fall asleep

sleeplessness

restless sleep

sleeplessness from restlessness, worries and exhaustion

frequent waking

sleeplessness from nervousness and excitability

restless sleep

INDICATIONS & USAGE SECTION

Uses*

addresses sleeplessness and/or restless sleep.

WARNINGS SECTION

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctorif symptoms persist for more than 3 days or worsen.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

children 3-11 years of age
  • chew 2 tablets at bedtime
  • do not swallow whole
children under 3 years of ageask a doctor before use

STORAGE AND HANDLING SECTION

Other information

store between 20°-25°C (68°-77°F) in a dry place out of direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic carnuaba wax, organic dextrose, organic maltodextrin, organic rice bran extract, vanilla lavender flavor

OTC - QUESTIONS SECTION

Questions?

1-855-436-3921

SPL UNCLASSIFIED SECTION

* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT EVALUATED BY THE FOOD AND DRUG ADMINISTRATION.
** X is a homeopathic dilution: see genexa.com for more information.

SPL UNCLASSIFIED SECTION

Bottle is safety sealed with a perforated neckband. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by:

Genexa Inc. Atlanta, GA 30318

genexa.com
Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

NDC 69676-0053-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Genexa

Homeopathic

Kids' Sleepology

Deep and Restful Sleep*

Relax and Sweet Dreams*

Wake Up Refreshed*

Organic Nighttime Sleep Aid*

Non-Habit Forming and Melatonin-Free

Made with Vanilla Lavender Flavor

No common allergens, artificial dyes or parabens

60 Chewable Tablets

Ages 3-11

Kids' SleepologyKids' Sleepology

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130857630006199GTIN-13: 0857630006199
EAN-13: 0857630006199
GTIN-12: 857630006199
UPC-A: 857630006199
GTIN storage (14 digits): 00857630006199		Kids Sleepology R-20210726.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69676-0053-12025-12-30C16284748780-12cef2736-7453-d83d-e063-dadaa90ab31fKIDS' SLEEPOLOGY
69676-0053-12025-01-30C16284748780-12cef2736-7453-d83d-e063-dadaa90ab31fKIDS' SLEEPOLOGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69676-0053-1Genexa Kids Sleepology1 in 1 CARTONTABLET, CHEWABLE14
69676-0053-1Genexa Kids Sleepology60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE604

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69676-005369676-0053-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ESCHSCHOLZIA CALIFORNICA9315HN272XACTIB
CARNAUBA WAXR12CBM0EIZIACT
MALTODEXTRIN7CVR7L4A2DIACT
RICE BRANR60QEP13ICIACT
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
VALERIANJWF5YAW3QWACTIB
MATRICARIA CHAMOMILLA WHOLE2Z4LRR776SACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
SCUTELLARIA LATERIFLORA TOPC6CNB75R61ACTIB
MELISSA OFFICINALIS LEAF50D2ZE9219ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
ALFALFADJO934BRBDACTIB
DEXTROSEIY9XDZ35W2IACT

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
Genexa Kids SleepologyALFALFA, CALCAREA PHOSPHORICA, CHAMOMILLA, ESCHSCHOLTZIA CALIFORNICA, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PULSATILLA, SCUTELLARIA LATERIFLORA, VALERIANA OFFICINALISGenexa Inc.ba0cd3c2-9883-9664-e053-2995a90a9fd42025-02-26WarningsExact identifier
ndc (package): 69676-0053-1
ndc (product): 69676-0053
ndc11 (package): 69676005301
spl id: 2f12abe7-5bb3-fa8e-e063-6394a90a6f47
spl set id: ba0cd3c2-9883-9664-e053-2995a90a9fd4

Reported adverse events (FAERS/openFDA)#

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