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

Sleepology for Children by

Drug Labeling and Warnings

Sleepology for Children 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** (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.

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

ASK DOCTOR

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

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

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

INGREDIENTS AND APPEARANCE

SLEEPOLOGY FOR CHILDREN 
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: 69676-0018
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD)	ALFALFA	6 [hp_X]
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]

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0018-1	1 in 1 CARTON	02/12/2018
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		02/12/2018

Labeler - Genexa Inc. (079751024)