Label: GERMA ARNICA MONTANA 30C- 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 9, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients                               Purpose

    Arnica Montana 30C                Pain, Bruises, Injuries Muscle Aches

  • PURPOSE

    Bruising & Swelling / Moreton e Hinchazon

    Aches & Pains / Dolores y Molestia Musuclar

    Joints Pain / Dolores de Articulacion

    Back Ache / Dolores de Espalda

    Stiffness / Rigidez

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Homeopathy is a scientific system of medicine which has been around for over 200 years. It is used worldwide to treat a wide array of symptoms and conditions naturally and without harmful side-effects.

  • DOSAGE & ADMINISTRATION

    Directions

    Slighly chew one table and allow to dissolve in mouth, 3 times a day. For best results avoid eating at least 15 minutes before or after taking the remedy.

  • WARNINGS

    Warnings

    If pregnant, breastfeeding or symptoms persist or worsen, discontinue use and consult a physician.  Do not use if inner seal is broken or missing.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Lactose, magnesium stearate

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    GERMA ARNICA MONTANA 30C 
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59561-101
    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
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59561-101-01100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/09/2015
    Labeler - Caribe Natural, Inc. (624210480)
    Establishment
    NameAddressID/FEIBusiness Operations
    Homeocare Laboratories Inc088248828manufacture(59561-101)
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