Label: GENEXA KIDS CALM KEEPER- aconitum napellus, calcarea phosphorica, chamomilla, gelsemium sepervirens, ignatia amara, kali carbonicum, passiflora incarnata, 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‡**

    Aconitum napellus 12X HPUS

    Calcarea phosphorica 8X HPUS

    Chamomilla 6X HPUS

    Gelsemium sempervirens 12X HPUS

    Ignatia amara 12X HPUS

    Kali carbonicum 8X HPUS

    Passiflora incarnata 3X HPUS

    Valeriana officinalis 3X HPUS

    ‡ Organic

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

  • PURPOSE

    Purpose

    stress and tension

    worry, stress and sleeplessness

    irritability and restlessness

    fatigue and restlessness

    tension and inability to think clearly

    oversensitivity and irritability

    restless sleep and worry

    fatigue and stress

  • INDICATIONS & USAGE

    Uses*

    addresses the following symptoms associated with stress:

    • irritability
    • sleeplessness
    • restlessness
    • nervousness
    • oversensitivity
  • 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 the onset of symptoms
    • do not swallow whole
    • repeat every 6 hours as needed
    children under 3 years of ageask a doctor before use
  • STORAGE AND HANDLING

    Other information

    store between 29-25° C (68-77° F) in a dry place out of direct sunlight

  • INACTIVE INGREDIENT

    Inactive ingredients

    organic carnauba 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.

    NOTE: THIS PRODUCT IS NOT INTENDED TO TREAT ADHD, AUTISM, OR ANXIETY DISORDERS
    ** X is a homeopathic dilution: see genexa.com for more information.

  • SPL UNCLASSIFIED SECTION

    Bottle is safety sealed. 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-20210624

    NDC 69676-0054-1

  • PRINCIPAL DISPLAY PANEL

    Genexa

    Homeopathic

    Kids' Calm Keeper

    Eases Worries & Tension*

    Reduces Fatigue*

    Lessens Irritability*

    Organic Calming and Relaxation Formula*

    Non-Habit Forming

    Made with Vanilla Lavender Flavor

    No common allergens, artificial dyes or parabens

    60 Chewable Tablets

    Ages 3+

    8A Calm-Keeper Kids_20210824

  • INGREDIENTS AND APPEARANCE
    GENEXA KIDS CALM KEEPER 
    aconitum napellus, calcarea phosphorica, chamomilla, gelsemium sepervirens, ignatia amara, kali carbonicum, passiflora incarnata, valeriana officinalis tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION8 [hp_X]
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S) MATRICARIA CHAMOMILLA WHOLE6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED12 [hp_X]
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE8 [hp_X]
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN3 [hp_X]
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP3 [hp_X]
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS12 [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 (Lavender) Imprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0054-11 in 1 CARTON02/01/2021
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/01/2021
    Labeler - Genexa Inc. (079751024)
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