Label: ARNICA MONTANA- arnica montana tablet

  • NDC Code(s): 53499-3533-2, 53499-3533-3
  • Packager: Schwabe North America
  • 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 October 12, 2020

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  • Active Ingredient

    Arnica montana 6X

  • Inactive Ingredient

    CELLULOSE

    LACTOSE MONOHYDRATE

    MAGNESIUM STEARATE

    SODIUM CROSCARMELLOSE

  • Dosage & Administration

    Dosage:  

                  Adults or children over 2 years: Take 3 tablets 4-6 times a day. 

                  Allow to dissolve under tongue. 

  • Indications 

    Temporarily relieves minor muscle or joint aches and pain; strains, sprains, bruises, backache or over-exertion.

  • Purpose

     For the temporary relief of minor muscle or joint aches and pain; strains, sprains, bruises, backache or over-exertion. 

  • Warning

    Do not take this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor. 

  • When Using

    When using this product if pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

  • Pregnancy and Breast Feeding

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

  • Keep out of reach of children.

    Keep out of reach of children.

  • Overdosage

     In case of overdose, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    Arnica montana 6X-21103534_5.jpg

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA  
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-3533
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    Colorwhite (white tablet) Scoreno score
    ShapeROUND (B&T) Size6mm
    FlavorImprint Code B;T
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-3533-2100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/200609/30/2019
    2NDC:53499-3533-31 in 1 CARTON01/01/200610/31/2025
    2250 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/200610/31/2025
    Labeler - Schwabe North America (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-3533)
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