Label: ARNICA MONTANA 3X, 6X, 12X, 30X, 200X- arnica montana root 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 August 18, 2022

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  • WARNINGS

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or

    worsen, a health professional should be consulted. Do not use if sensitivity to Hendel Arnica montana 3X, 6X, 12X, 30X, 200X or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS

    • Symptoms of bruising

    • Pain

  • ACTIVE INGREDIENT

    Arnica Montana 3X, 6X, 12X, 30X, 200X

  • INACTIVE INGREDIENT

    Lactose, Magnesium stearate

  • DIRECTIONS

    Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.

  • USES

    For the temporary relief of:

    • Symptoms of bruising

    • Pain

  • PRINCIPAL DISPLAY PANEL

    Arnica Montana

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  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 3X, 6X, 12X, 30X, 200X 
    arnica montana root tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1112
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code Leafman
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-1112-2100 in 1 BOTTLE; Type 0: Not a Combination Product08/01/201602/28/2027
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/201602/28/2027
    Labeler - MediNatura Inc (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura Inc102783016manufacture(62795-1112)
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