Label: ARNICA MONTANA 30X HPUS- arnica montana tablet

  • 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 April 27, 2022

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  • ACTIVE INGREDIENT:

    Arnica Montana 30X HPUS.

  • PURPOSE:

    Anti-Inflammatory

  • WARNINGS:

    If pregnant or breast-feeding ask a health professional before use. Discontinue use if any adverse reactions occur. Contact your physician, if symptoms do not subside within 14 days.

    KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

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

  • KEEP OUT OF REACH OF CHILDREN:

    KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Adults, three tablets, three times a day. Not intended for children under 12 years of age. This product is a sublingual application.

  • INDICATION:

    Anti-Inflammatory

  • INACTIVE INGREDIENTS:

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

  • QUESTIONS:

    Formulated and Distributed

    by VitaMedica Corp.

    Henderson, NV 89014

    888-367-8605 VitaMedica.com

    ©2022 VitaMedica Corporation

    NDC 80004-005-67

  • PACKAGE DISPLAY LABEL

    VitaMedica

    Arnica Montana

    30X HPUS

    REDUCES

    Bruising, Swelling & Pain

    NATURAL REMEDY

    STIMULATES HEALING

    Recommended by Plastic Surgeons

    Homeopathic Medicine

    150 Sublingual Tablets

    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 WHOLE - UNII:O80TY208ZW) ARNICA MONTANA WHOLE30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUND (TABLET) Size6mm
    FlavorImprint Code V
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80004-005-67150 in 1 BOTTLE; Type 0: Not a Combination Product03/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/14/2022
    Labeler - 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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