Label: ARNICA MONTANA pellet

  • 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 8, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Arnica Montana HPUS 30c

  • DOSAGE & ADMINISTRATION

    Directions: (adults and children 12 years and older) Dissolve 5 pellets under the tongue 3 times per day until symptoms are relieved or as directed by a doctor.

  • USES

    For the conditions listed under purposes or as directed by a doctor.

  • WARNINGS

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

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Store at room temperature.

  • DO NOT USE

    other information: Do not use if pellet dispenser seal is broken.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Lactose, sucrose.

  • PURPOSE

    Purposes: relief of muscle aches and soreness, swelling, stiffness and bruising.

  • PRINCIPAL DISPLAY PANEL

    365_ArnicaPelletTube-1052011

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 
    arnica montana pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42681-0508
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    lactose (UNII: J2B2A4N98G)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42681-0508-180 in 1 CYLINDER; Type 0: Not a Combination Product11/23/201106/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/23/2011
    Labeler - Whole Foods Market (196175616)
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