Sleepology for Children

Manufacturer
Genexa Inc.
Effective date
2021-01-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:54:23

Label at a glance#

ProductSleepology for Children
Active ingredientALFALFA, ESCHSCHOLZIA CALIFORNICA, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, MATRICARIA CHAMOMILLA WHOLE, TRIBASIC CALCIUM PHOSPHATE, SCUTELLARIA LATERIFLORA TOP, MELISSA OFFICINALIS LEAF, PULSATILLA VULGARIS
Label structure16 sections

Storage and handling

Other information Store between 15°-30°C (59°-86°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** (in each tablet)

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 latiflora ‡ 3X HPUS

Valeriana officinalis ‡ 6X HPUS

‡ Certified 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 - ASK DOCTOR SECTION

Ask a doctor before use in children under 3 years of age.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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 age: ask a doctor before use.

STORAGE AND HANDLING SECTION

Other information

  • Store between 15°-30°C (59°-86°F) in a dry place out of direct sunlight.

INACTIVE INGREDIENT SECTION

Inactive ingredients

organic carnuaba wax, organic compliant natural flavor, organic dextrose, organic maltodextrin, organic rice bran extract

SPL UNCLASSIFIED SECTION

* Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
** X is a homeopathic dilution: see www.genexa.com for more information.
Patent Pending

SPL UNCLASSIFIED SECTION

THE Genexa® PLEDGE
WE PLEDGE TO DELIVER THE HIGHEST QUALITY MEDICINES.
All our medicines are made of pure, clean, certified organic and non-GMO ingredients.

Genexa medicines maintain the highest standards in manufacturing and are made in the USA with globally sourced organic ingredients.

We pioneered the organic technology (patent pending) that eliminates harmful synthetics from our proprietary chewable tablet.
Our chewable medicines are free of lactose, gluten, artificial preservatives, flavorings and colors.

Distributed by: Genexa Inc.
Beverly Hills, CA 90211
www.genexa.com
Certified Organic by SCS Global Services

OTHER SAFETY INFORMATION

BOTTLE IS SAFETY SEALED. DO NOT USE IF BOTTLE SEAL IS DISTURBED OR MISSING.

SPL UNCLASSIFIED SECTION

Genexa®
THE HEALTHIER MEDICINE®
Genexa was founded on the belief that medicine should not only be EFFECTIVE and UNQUESTIONABLY SAFE, but that it should be HEALTHY for you and your family.
We're also proud to be a Certified B Corporation using business as a force for good.
Questions? Comments?
1-855-GENEXA-1
hello@genexa.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Children's Genexa®

THE HEALTHIER MEDICINE®

NDC 69676-0018-1

Ages 3+

SAFE & NON-HABIT FORMING

MELATONIN-FREE

SLEEPOLOGY®

ORGANIC NIGHTTIME SLEEP AID*

  • Deep and restful sleep
  • Relax and Sweet Dreams
  • Wake Up Refreshed*

60 CHEWABLE TABLETS

HOMEOPATHIC

VANILLA LAVENDER FLAVOR

USDA ORGANIC

NON GMO Project VERIFIED

Sleepology Child_20181129Sleepology Child_20181129

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
69676-001869676-0018-1

Ingredients#

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

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

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
ba0d81fe-1e6a-2c64-e053-2995a90a219b70952a5a-efe9-47d4-e053-2991aa0a9df42021-01-29WarningsExact identifier
spl id: ba0d81fe-1e6a-2c64-e053-2995a90a219b
spl set id: 70952a5a-efe9-47d4-e053-2991aa0a9df4

Reported adverse events (FAERS/openFDA)#

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