Label: ARNICA- arnica montana tablet, soluble

  • NDC Code(s): 54973-3084-1, 54973-3084-3
  • Packager: Hyland's
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Arnica Montana 30X HPUS

    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

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  • Purpose

    bruising, swelling, stiffness, muscle soreness and pain

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  • Uses

    Temporarily relieves bruising, swelling, stiffness, and muscle soreness due to injuries or overexertion.

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  • Warnings

    As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if symptoms persist for more than 7 days or worsen.

    Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately.

    Do not use if imprinted tamper band is broken or missing.

    In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

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  • Directions

    Adults and children 12 years and over dissolve 1-2 tablets under tongue 4 times per day; 1-2 tablets may be taken in anticipation of strenuous activity or injury
    Children ages 6-12 years dissolve 1 tablet under tongue 4 times per day; 1 tablet may be taken in anticipation of strenuous activity or injury.
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  • Inactive ingredients

    Acacia Gum, Lactose N.F.

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  • PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

    SINCE 1903
    Hyland's®

    Arnica 30X

    ADVANCE DEFENSE
    PAIN RELIEF FORMULA

    50 Quick-Dissolving Tablets

    MADE IN USA

    Principal Display Panel - 50 Tablet Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    ARNICA 
    arnica montana tablet, soluble
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54973-3084
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 30 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE  
    ACACIA  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3084-1 50 in 1 BOTTLE, PLASTIC
    2 NDC:54973-3084-3 4 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 12/17/2008
    Labeler - Hyland's (028570695)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 MANUFACTURE(54973-3084)
    Establishment
    Name Address ID/FEI Business Operations
    MERICAL, INC. 029644978 MANUFACTURE(54973-3084)
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