Label: ARNICA RECOVERY- arnica montana tablet

  • NDC Code(s): 34666-010-12, 34666-010-60
  • Packager: NARTEX LABORATORIOS HOMEOPATICOS SA DE CV
  • 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 February 27, 2018

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  • ACTIVE INGREDIENT

    Arnica montana 6C HPUS

  • PURPOSE

    Arnica montana.......6C HPUS*..........Anti-inflammatory

    *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.  C is a homeopathic dilution.  See www.nartexlabsusa.com for more information.  Active ingredients are preparaed in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

  • INDICATIONS & USAGE

     For the temporary relief of

    • sore muscles
    • bruises
    • sprains

    as per homeopathic materia medica

    Product uses are based on Homeopathic Materia Medica.  These "Uses" have not been evaluated by teh Food and Drug Administration. This product has not been clinically tested by Nartex Labs USA, Inc.

  • WARNINGS

    Do not use if you have an allergy or hypersensitivity to the components of the formula.

  • STOP USE

    Stop and ask a physician if:

    • condition worsens
    • if symptoms persist for more than 7 days or clear up and occur again within a few days
    • rash develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, consult a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • adults and children 4 years of age and older: take 2 tablets every 6 hours, slowly dissolving in mouth
    • children under 4 years of age: consult a physician
  • STORAGE AND HANDLING

    store in a cool and dry place

  • INACTIVE INGREDIENT

    Gelatin, lactose, magnesium stearate, potato starch, talc

  • QUESTIONS

    Questions or comments?  informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST

  • DESCRIPTION

    Distributed by:

    Nartex Labs USA, Inc.

    11711 Memorial Dr. #685

    Houston TX 77024

    www.nartexlabsusa.com

  • DESCRIPTION

    Product claims are based on Homeopathic Materia Medica. This product has not been clinically tested by Nartex.

    Keep carton. It contains important information.

    For you protection, this bottle has a seal around the neck.  Attention: do not use if hte neck seal is broken.

    This product is HOMEOPATHIC.  Its claim and efficacy are based on homeopathic research and clinical experience.  This product has not been evaluated for efficacy by FDA with the same rules and procedures as those for other non-homeopathic drugs.  For more information on homeopathy visit www.nartexlabsusa.com before using this product.

  • PRINCIPAL DISPLAY PANEL

    NDC 34666-010-60

    Arnica

    Recovery Nartex

    For Sore Muscles and Bruises*

    Directions

    2 tablets every 6 hours**

    Homeopathic

    60 Tablets

    *Based on Homeopathic Materia Medica

    **See directions at the Back.

    ArnicaTabletsCarton

  • INGREDIENTS AND APPEARANCE
    ARNICA RECOVERY 
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-010-6060 in 1 BLISTER PACK; Type 0: Not a Combination Product07/01/2011
    2NDC:34666-010-1212 in 1 BLISTER PACK; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/01/2011
    Labeler - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Registrant - NARTEX LABORATORIOS HOMEOPATICOS SA DE CV (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    NARTEX LABORATORIOS HOMEOPATICOS SA DE CV589914576manufacture(34666-010)
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