Label: ARNICA MONTANA- whole arnica plant 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 June 2, 2010

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  • INDICATIONS & USAGE

    Free from yeast, wheat, corn, and soy.
    DIRECTIONS: Dissolve 3 or 4 pellets
    in mouth or under tongue 3 times a day or as directed by a physician.
    Children 2 years and older take 1/2
    adult dose.
    INDICATIONS: To be used according
    to standard homeopathic indications
    for self limiting conditions such as
    those indicated on the front panel or as directed by a physician.
    Warnings: *Use only if cap and
    seal are unbroken. * Keep this and all medications out of reach of children.
    * If symptoms persist for more then 3
    days, consult your physician.
    *As with any drug, if your are pregnant or nursing a baby, seek the advice of a
    health professional before using this product.*Store tightly closed in a cool, dark place.
    Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768

  • PRINCIPAL DISPLAY PANEL

    ARNICA MONTANA 6X

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 
    whole arnica plant pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10191-1242
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10191-1242-2164 in 1 VIAL, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/06/2003
    Labeler - Remedy Makers (018543582)