GENEXA KIDS SLEEPOLOGY- alfalfa, calcarea phosphorica, chamomilla, eschscholtzia californica, melissa officinalis, passiflora incarnata, pulsatilla, scutellaria lateriflora, valeriana officinalis tablet, chewable

Genexa Kids Sleepology by

Drug Labeling and Warnings

Genexa Kids Sleepology by is a Homeopathic medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Keep outer package for complete product information

Drug Facts

ACTIVE INGREDIENT

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 latiflora 3X HPUS

Valeriana officinalis 6X HPUS

‡ Organic

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

PURPOSE

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

Uses*

addresses sleeplessness and/or restless sleep.

WARNINGS

Warnings

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

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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

Other information

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

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

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

R-20210726

NDC: 69676-0053-1

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

INGREDIENTS AND APPEARANCE

GENEXA KIDS SLEEPOLOGY 
alfalfa, calcarea phosphorica, chamomilla, eschscholtzia californica, melissa officinalis, passiflora incarnata, pulsatilla, scutellaria lateriflora, valeriana officinalis tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0053
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X)	ESCHSCHOLZIA CALIFORNICA	6 [hp_X]
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	6 [hp_X]
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X]
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S)	MATRICARIA CHAMOMILLA WHOLE	6 [hp_X]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR)	TRIBASIC CALCIUM PHOSPHATE	8 [hp_X]
SCUTELLARIA LATERIFLORA TOP (UNII: C6CNB75R61) (SCUTELLARIA LATERIFLORA TOP - UNII:C6CNB75R61)	SCUTELLARIA LATERIFLORA TOP	3 [hp_X]
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) (MELISSA OFFICINALIS LEAF - UNII:50D2ZE9219)	MELISSA OFFICINALIS LEAF	3 [hp_X]
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X]
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD)	ALFALFA	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
RICE BRAN (UNII: R60QEP13IC)
DEXTROSE (UNII: IY9XDZ35W2)

Product Characteristics
Color	white (Off-white)	Score	no score
Shape	ROUND	Size	10mm
Flavor	VANILLA (Vanilla Lavender)	Imprint Code	G
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0053-1	1 in 1 CARTON	01/28/2021
1		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/28/2021

Labeler - Genexa Inc. (079751024)