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

Drug Label Information

Updated 07/13

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  • 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 Item Code (Source) NDC:54973-3084
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_X]
    Inactive Ingredients
    Ingredient Name Strength
    LACTOSE (UNII: J2B2A4N98G)  
    ACACIA (UNII: 5C5403N26O)  
    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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