Label: ARNICA MONTANA 30X HPUS- arnica montana tablet

  • NDC Code(s): 80004-005-77
  • Packager: Grove Acquisition Subsidiary, Inc. dba VitaMedica
  • 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 May 18, 2022

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  • ACTIVE INGREDIENT:

    Arnica Montana 30X.

  • PURPOSE:

    Temporarily relieves these symptoms due to soft tissue injury:

    • Bruising • Swelling • Pain

    • Stiffness • Muscle Soreness

  • WARNINGS:

    Ask a doctor before use if pregnant or breastfeeding.

    Stop use and ask a physician if

    • Any adverse reactions occur

    • Symptoms persist for more than 14-days or worsen

    Keep this and all medications out of reach of children.

    In case of an emergency or accidental overdose, contact a medical professional or Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep this and all medications out of reach of children.

    In case of an emergency or accidental overdose, contact a medical professional or Poison Control Center immediately.

  • DIRECTIONS:

    • This product is a sublingual application.

    • Do not handle the tablets. Instead, drop tablets directly under the tongue and let dissolve naturally.

    Adults and children 12 years and over. Take 2 tablets, 3 times a day.

    Not intended for children under 12 years.

  • INDICATIONS:

    Temporarily relieves these symptoms due to soft tissue injury:

    • Bruising • Swelling • Pain

    • Stiffness • Muscle Soreness

  • OTHER INFORMATION:

    • Do not use if seal is broken or shows any signs of tampering.

    • Store at 68-77 F (20-25 C).

  • INACTIVE INGREDIENTS:

    Copovidone, Crospovidone, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Silicon Dioxide, Sorbitol.

  • QUESTIONS:

    Formulated and Distributed by

    VitaMedica 

    Henderson, NV 89014

    888-367-8605

    customerservice@VitaMedica.com

    For more Information: VitaMedica.com

    ©2022 VitaMedica Corporation

    NDC 80004-005-77

  • PACKAGE LABEL DISPLAY:

    VitaMedica

    Arnica

    Montana

    30X HPUS

    REDUCES

    Bruising, Swelling & Pain

    NATURAL REMEDY

    STIMULATES HEALING

    Recommended by Plastic Surgeons

    Convenient 5-Day Blister Pack

    Homeopathic Medicine

    30 Sublingual Tablets

    Arnica Montana 30X HPUS

    Arnica Montana 30X HPUS

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA  30X HPUS
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80004-005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80004-005-771 in 1 CARTON05/18/2022
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/18/2022
    Labeler - Grove Acquisition Subsidiary, Inc. dba VitaMedica (118496706)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(80004-005) , api manufacture(80004-005) , label(80004-005) , pack(80004-005)
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