Label: ARNICA MONTANA tablet

  • NDC Code(s): 53499-3571-2, 53499-3571-3
  • Packager: Schwabe North America, Inc.
  • 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 May 20, 2022

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  • Active Ingredient

    Arnica Montana 30C

    Inactive Ingredients

    CELLULOSE

    LACTOSE MONOHYDRATE

    MAGNESIUM STEARATE

    SODIUM CROSCARMELLOSE 

  • Dosage and Administration

    Adults or children over 2 years:  Take 3 tablets 1 to 3 times per day.

    Allow to dissolve under tongue. 

    Indications and Usage

    Temporarily relieves minor muscle or joint aches and pains from strains, sprains, bruises, backache, over extertion.

    Purpose

    For the temporary relief of minor muscle or joint aches and pains from strains, sprains, bruises, backache and over exertion.

  • Warnings

    Do not use 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 serous condition.

  • Pregnancy or Breast Feeding

    If you are pregnant or breast-feeding, ask a healthcare professional before use.

  • Keep out of reach of children

    Keep out of reach of children

  • Overdose

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

  • PRINCIPAL DISPLAY PANEL

    21203574_Arnica montana-30C_05.jpg

  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA 
    arnica montana tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-3571
    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
    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:53499-3571-2100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/200603/31/2027
    2NDC:53499-3571-3250 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product01/01/200603/31/2027
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/200603/31/2027
    Labeler - Schwabe North America, Inc. (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. deC.V.812805901manufacture(53499-3571)
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