Label: SLEEPOLOGY- alfalfa, avena sativa, chamomilla, eschscholtzia californica, gelsemium sempervirens, nux moschata, passiflora incarnata, piper methysticum, valeriana officinalis tablet, chewable

  • NDC Code(s): 69676-0012-1, 69676-0012-3
  • Packager: Genexa Inc.
  • 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 May 9, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Keep outer package for complete product information

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients **

    Alfalfa 6X HPUS

    Avena sativa 6X HPUS

    Chamomilla 6X HPUS

    Eschscholtzia californica 6X HPUS

    Gelsemium sempervirens 12X HPUS

    Nux moschata 9X HPUS

    Passiflora incarnata 6X HPUS

    Piper methysticum 6X 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

    sleeplessness from nervousness and exhaustion

    inability to fall asleep

    sleeplessness from stress

    sleeplessness from pain, irritability and excitability

    frequent waking

    sleeplessness from worries and restlessness

    inability to fall asleep

    restless sleep

  • INDICATIONS & USAGE

    Uses*

    addresses sleeplessness and/or restless sleep.

  • WARNINGS

    Warnings

  • STOP USE

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age and older
    • chew 2 tablets at bedtime
    • do not swallow whole
    children 3-11 years of age
    • chew 1 tablet 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 neck band. DO NOT use if bottle seal is disturbed or missing.

    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-20220209

    NDC 69676-0012-1

  • PRINCIPAL DISPLAY PANEL

    Genexa®

    Sleepology

    Non-Habit Forming & Melatonin-Free

    Organic Nighttime Sleep Aid*

    Deep and Restful Sleep*

    Wake Up Refreshed*

    Relax and Sweet Dreams*

    Know your ingredients

    Made without: common allergens, artificial dyes or parabens

    Homeopathic

    Vanilla Lavender Flavor

    60 Chewable Tablets

    5ASleepologyAdult2022_02_09

  • INGREDIENTS AND APPEARANCE
    SLEEPOLOGY 
    alfalfa, avena sativa, chamomilla, eschscholtzia californica, gelsemium sempervirens, nux moschata, passiflora incarnata, piper methysticum, valeriana officinalis tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP6 [hp_X]
    ALFALFA (UNII: DJO934BRBD) (ALFALFA - UNII:DJO934BRBD) ALFALFA6 [hp_X]
    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]
    NUTMEG (UNII: AEE24M3MQ9) (NUTMEG - UNII:AEE24M3MQ9) NUTMEG9 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN6 [hp_X]
    PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) (PIPER METHYSTICUM ROOT - UNII:BOW48C81XP) PIPER METHYSTICUM ROOT6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S) MATRICARIA CHAMOMILLA WHOLE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    RICE BRAN (UNII: R60QEP13IC)  
    Product Characteristics
    Colorwhite (Off-white) Scoreno score
    ShapeROUNDSize10mm
    FlavorVANILLAImprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0012-11 in 1 CARTON03/21/2016
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:69676-0012-32 in 1 POUCH; Type 0: Not a Combination Product10/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/21/2016
    Labeler - Genexa Inc. (079751024)