Label: GENEXA ARNICA PAIN- arnica montana, calendula officinalis, ledum palustre, rhus toxicodendron, ruta graveolens 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 March 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Keep outer package for complete product information

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients‡**

    Arnica montana 30X HPUS

    Calendula officinalis 6X HPUS

    Ledum palustre 6X HPUS

    Rhus toxicodendron 12X HPUS

    Ruta graveolens 6X HPUS

    ‡ Organic

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

  • PURPOSE

    Purpose

    trauma, muscle pain, muscle soreness, stiffness, swelling, bruising, strains and sprains

    cuts, scrapes and discoloration from bruising

    swelling, stiffness and bruising

    joint pain, joint soreness and joint stiffness

    muscle pain and muscle soreness

  • INDICATIONS & USAGE

    Uses*

    • addresses muscle pain and stiffness due to minor injuries, overexertion and falls.
    • addresses pain, swelling and discoloration from bruises.
  • WARNINGS

    Warnings

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

    If pregnant or breastfeeding, ask a health professional before use.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 12 years of age and older
    • chew 2 tablets at the onset of symptoms
    • do not swallow whole
    • repeat every 4-6 hours as needed
    children 3-11 years of age
    • chew 1 tablet at the onset of symptoms
    • do not swallow whole
    • repeat every 4-6 hours as needed
    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 carnauba wax, organic dextrose, grape flavor, 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 30318

    genexa.com

    Certified Organic by SCS Global Services

  • SPL UNCLASSIFIED SECTION

    Made in the USA with globally sourced ingredients

    NDC 69676-0044-2

  • PRINCIPAL DISPLAY PANEL

    Genexa®

    Arnica Pain

    Organic Pain Relief Formula*

    Muscle Pain & Soreness*

    Bruises & Swelling*

    Joint Pain & Stiffness*

    Made without: common allergens, artificial dyes, or parabens

    Homeopathic

    100 Chewable Tablets

    Grape Flavor

    6A_Carton_R-20220408

  • INGREDIENTS AND APPEARANCE
    GENEXA ARNICA PAIN 
    arnica montana, calendula officinalis, ledum palustre, rhus toxicodendron, ruta graveolens tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0044
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF12 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP6 [hp_X]
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG6 [hp_X]
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP6 [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
    FlavorGRAPEImprint Code G
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69676-0044-21 in 1 CARTON12/20/2020
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2020
    Labeler - Genexa Inc. (079751024)
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