Label: ARNICA- 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 July 7, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Arnica Montana 30C HPUS

  • Purpose

    To reduce exhaustion and help recovery after physical activity or accidents

    The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopeia of the United States.

  • Uses

    For the relief of exhaustion associated with physical activity

  • Warnings

    Do not use if the blister pack is broken.

    Ask a doctor before use in children under 2 years of age.

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

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

    Keep out of reach of children.

  • Directions

    AgeDose
    Adults and Children 2 years and overChew two tablets after exercise or physical activity - work or sports. Best taken separately from meals. Can be taken with all other types of medication.
    Under 2 yearsAsk a doctor.
  • Other Information

    • store under 86°F (30°C)
    • No drug interactions
    • Non-drowsy
  • Inactive ingredients

    Dextrose and separating agents magnesium stearate and silicon dioxide.

  • SPL UNCLASSIFIED SECTION

    Distributed to retailers by
    L.C. Industries, Inc
    2781 Katherine Way
    Elk Grove Village, IL 60007

  • PRINCIPAL DISPLAY PANEL - 32 Tablet Blister Pack Box

    ARNICA

    NDC 59672-0032-0

    For the temporary relief of:
    Bruising, Swelling, Stiffness
    Muscle and joint soreness
    Mental or physical exhaustion

    Contains 32 Tablets

    Principal Display Panel - 32 Tablet Blister Pack Box
  • INGREDIENTS AND APPEARANCE
    ARNICA 
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59672-0032
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    Dextrose (UNII: IY9XDZ35W2) 248 mg
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Magnesium stearate (UNII: 70097M6I30)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code ML
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59672-0032-01 in 1 BOX
    132 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC03/07/2014
    Labeler - LC Industries (069952018)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miers Laboratories594355794MANUFACTURE(59672-0032)
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