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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 20, 2023

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  • 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 ageask 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

    Kids' Sleepology

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0053
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X) (ESCHSCHOLZIA CALIFORNICA - UNII:9315HN272X) ESCHSCHOLZIA CALIFORNICA6 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP6 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S) MATRICARIA CHAMOMILLA WHOLE6 [hp_X]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE8 [hp_X]
    SCUTELLARIA LATERIFLORA TOP (UNII: C6CNB75R61) (SCUTELLARIA LATERIFLORA TOP - UNII:C6CNB75R61) SCUTELLARIA LATERIFLORA TOP3 [hp_X]
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) (MELISSA OFFICINALIS LEAF - UNII:50D2ZE9219) MELISSA OFFICINALIS LEAF3 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS12 [hp_X]
    ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    RICE BRAN (UNII: R60QEP13IC)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    Product Characteristics
    Colorwhite (Off-white) Scoreno score
    ShapeROUNDSize10mm
    FlavorVANILLA (Vanilla Lavender) Imprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0053-11 in 1 CARTON01/28/2021
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/28/2021
    Labeler - Genexa Inc. (079751024)
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