CALM KEEPER (ACONITUM NAPELLUS, CALCAREA PHOSPHORICA, CHAMOMILLA, GELSEMIUM SEPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA

CALM KEEPER (ACONITUM NAPELLUS, CALCAREA PHOSPHORICA, CHAMOMILLA, GELSEMIUM SEPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS) TABLET, CHEWABLE [GENEXA
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NDC 69676-0008-1
Set ID 7900262d-90fd-6c08-e053-2991aa0a77f9
Category HUMAN OTC DRUG LABEL
Packager Genexa Inc.
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients** (in each tablet)

    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

    ‡ Certified Organic

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

  • PURPOSE

    Purpose

    stress, agitation and hypersensitivity

    anxiety and sleeplessness

    irritability and restlessness

    fatigue and restlessness

    inability to think clearly

    oversensitivity and irritability

    restless sleep and stress

    nervousness & digestive symptoms due to stress

  • INDICATIONS & USAGE

    Uses*

    addresses the following symptoms:

    • irritability
    • restlessness
    • oversensitivity
    • sleeplessness
    • nervousness
  • WARNINGS

    Warnings

  • STOP USE

    Stop use and ask a doctorif 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 the onset of symptoms
    • do not swallow whole
    • repeat every 6 hours as needed
    • 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 carnauba 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

    MADE IN THE USA WITH GLOBALLY SOURCED INGREDIENTS

  • SPL UNCLASSIFIED SECTION

    THE Genexa® PLEDGE

    WE PLEDGE TO DELIVER THE HIGHEST QUALITY MEDICINES.

    All our products are made with clean, certified organic and non-GMO Ingredients.

    Genexa products 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 products are free of artificial dyes, flavors and preservatives.

    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

    Genexa®

    THE HEALTHIER MEDICINE®

    Genexa was founded on the belief that medicine should not only be UNQUESTIONABLY SAFE, but that it should be HEALTHY for you and your family.

    We're also very proud to be a Certified B Corporation using business as a force for good.

    Questions? Comments?

    1-855-GENEXA-1

    hello@genexa.com

  • PRINCIPAL DISPLAY PANEL

    Children's

    Genexa®

    THE HEALTHIER MEDICINE®

    NDC 69676-0008-1

    Ages 3+

    NO DRUG INTERACTIONS

    ORGANIC & SAFE

    CALM KEEPER TM

    CALMING & RELAXATION*

    • Restlessness & Irritability*
    • Inability to Concentrate*
    • Fatigue*

    60 CHEWABLE TABLETS

    HOMEOPATHIC

    VANILLA LAVENDER FLAVOR

    USDA ORGANIC

    NON GMO Project VERIFIED

    Calmkeeper_20191110

  • INGREDIENTS AND APPEARANCE
    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:69676-0008
    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:69676-0008-11 in 1 CARTON07/20/201808/01/2023
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/20/201808/01/2023
    Labeler - Genexa Inc. (079751024)

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