Label: COLD CRUSH CHILDRENS- allium cepa, belladonna, bryonia alba, chamomilla, echinacea angustifolia, euphrasia officinalis, gelsemium sempervirens, ipecacuanha, pulsatilla, sambucus nigra 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 June 11, 2020

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  • SPL UNCLASSIFIED SECTION

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients‡** (in each tablet)

    Aconitum napellus 12X HPUS

    Allum 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

    ‡ Certified 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 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 4-6 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 acai berry flavor, organic carnauba wax, 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 from 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 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 69676-0005-1

    Ages 3+

    NON-DROWSY / ORGANIC & SAFE

    COLD CRUSH®

    COLD & COUGH*

    • Congestion & Mucus*
    • Cough & Sore Throat*
    • Runny Nose & Sneezing*

    60 CHEWABLE TABLETS

    HOMEOPATHIC

    ORGANIC ACAI BERRY FLAVOR

    USDA ORGANIC

    NON GMO Project VERIFIED

    Cold crush children 20191110

  • INGREDIENTS AND APPEARANCE
    COLD CRUSH CHILDRENS 
    allium cepa, belladonna, bryonia alba, chamomilla, echinacea angustifolia, euphrasia officinalis, gelsemium sempervirens, ipecacuanha, pulsatilla, sambucus nigra tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0005
    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:69676-0005-11 in 1 CARTON07/03/2018
    160 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/03/2018
    Labeler - Genexa Inc. (079751024)
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