Label: ARNICA- arnica montana tablet, soluble

  • NDC Code(s): 54973-3084-1, 54973-3084-3, 54973-3084-5
  • Packager: Hyland's 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 April 24, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Arnica Montana 30X HPUSbruising, swelling, stiffness, muscle soreness and pain

  • "HPUS" is the Homeopathic Pharmacopœia of the United States.

  • Uses

    ■ Helps temporarily relieve symptoms of muscle bruising, pain, swelling, stiffness or soreness due to minor injuries or overexertion

  • Warnings

  • STOP USE

    Stop use and ask a doctor if symptoms persist more than 7 days or worsen.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    ■ Use as directed.

    Adults and children
    12 years and over

    At onset of symptoms, dissolve 1-2 tablets under tongue

    every 4 hours as needed. If the initial dosage is not providing

    immediate relief, dissolve 1 tablet under tongue every

    15 minutes until relieved, up to 6 doses.
    Children 6 years
    to under 12 years     		At onset of symptoms, dissolve 1 tablet under tongue
    every 4 hours as needed. If the initial dosage is not providing
    immediate relief, dissolve 1 tablet under tongue every
    15 minutes until relieved, up to 6 doses.

  • Inactive ingredients

    Acacia Gum, Lactose.

  • Questions?

    www.hylands.com or care@hylands.com

  • SPL UNCLASSIFIED SECTION

    *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • OTHER SAFETY INFORMATION

    DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PURPOSE

    Helps temporarily relieve symptoms of muscle bruising, pain, swelling, stiffness or soreness due to minor injuries or overexertion.

  • PRINCIPAL DISPLAY PANEL

    carton.

    label..

  • PRINCIPAL DISPLAY PANEL

    label2

  • INGREDIENTS AND APPEARANCE
    ARNICA 
    arnica montana tablet, soluble
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3084
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    ACACIA (UNII: 5C5403N26O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3084-150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2008
    2NDC:54973-3084-34 in 1 PACKET; Type 0: Not a Combination Product12/17/2008
    3NDC:54973-3084-5100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/17/2008
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3084) , pack(54973-3084) , label(54973-3084)
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