Label: GENEXA KIDS COLD CRUSH- aconitum napellus, allium cepa, bryonia alba, chamomilla, echinacea angustifolia, euphrasia officinalis, gelsemium sempervirens, ipecacuanha, pulsatilla, sambucus nigra tablet, chewable

  • Category: HUMAN OTC DRUG LABEL

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 March 1, 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

    Allium cepa 6X HPUS

    Bryonia alba 9X HPUS

    Chamomilla 6X HPUS

    Echinacea angustifolia 6X HPUS

    Euphrasia officinalis 6X HPUS

    Gelsemium sempervirens 12X HPUS

    Ipecacuanha 12X HPUS

    Pulsatilla 9X HPUS

    Sambucus nigra 6X HPUS

    ‡ Organic

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

  • PURPOSE

    Purpose*

    dry cough and wet cough

    sneezing, runny nose and nasal discharge

    sinus pain and stuffy nose

    nasal congestion

    sore throat and dry throat

    chest congestion

    headache and body aches

    loss of smell

    mucus and loss of taste

    restless sleep

  • INDICATIONS & USAGE

    Uses*

    addresses symptoms associated with the common cold, such as:

    • chest congestion
    • nasal congestion
    • runny nose
    • cough
    • sore throat
    • sneezing
  • WARNINGS

    Warnings

  • STOP USE

    Stop use and ask a doctor if

    • difficulty breathing, vomiting, skin rash, diarrhea or fever above 100°F (38°C) develops
    • symptoms persist for more than 2 days or worsen.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    children 4-11 years of age
    • chew 2 tablets at the onset of symptoms
    • do not swallow whole
    • repeat every 4-6 hours as needed
    children under 4 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 acai berry flavor, organic carnauba wax, organic dextrose, organic maltodextrin, organic rice bran extract

  • 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/faq for more information.

  • SPL UNCLASSIFIED SECTION

    Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

    Patent Pending | Distributed by:

    Genexa Inc. Atlanta, GA 30324

    genexa.com

    Certified Organic by SCS Global Services

  • SPL UNCLASSIFIED SECTION

    Made in the USA with globally sourced ingredients

    R-20221031

    NDC 69676-0049-1

  • PRINCIPAL DISPLAY PANEL

    Genexa®
    Ages 4-11
    Kids' Cold Crush ®

    Non-Drowsy Organic Cold & Cough*
    Congestion & Mucus*
    Cough & Sore Throat*
    Runny Nose & Sneezing*
    Know your ingredients
    Made without: common allergens, artificial sweeteners or parabens
    Homeopathic
    60 Chewable Tablets

    Organic AçaÍ Berry Flavor

    1A_Carton R-20221031

  • INGREDIENTS AND APPEARANCE
    GENEXA KIDS COLD CRUSH 
    aconitum napellus, allium cepa, bryonia alba, chamomilla, echinacea angustifolia, euphrasia officinalis, gelsemium sempervirens, ipecacuanha, pulsatilla, sambucus nigra tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0049
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT9 [hp_X]
    MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S) (MATRICARIA CHAMOMILLA WHOLE - UNII:2Z4LRR776S) MATRICARIA CHAMOMILLA WHOLE6 [hp_X]
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA6 [hp_X]
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT12 [hp_X]
    IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC12 [hp_X]
    PULSATILLA PRATENSIS (UNII: 8E272251DI) (PULSATILLA PRATENSIS - UNII:8E272251DI) PULSATILLA PRATENSIS9 [hp_X]
    SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER6 [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)  
    ACAI (UNII: 46AM2VJ0AW)  
    Product Characteristics
    Colorwhite (Off-white) Scoreno score
    ShapeROUNDSize10mm
    FlavorBERRYImprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0049-11 in 1 CARTON07/31/2020
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/31/2020
    Labeler - Genexa Inc. (079751024)
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