Label: ARNICA MONTANA - arnica montana tablet, orally disintegrating

  • NDC Code(s): 65111-002-01, 65111-002-74
  • Packager: VITAMEDICA INC
  • 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 08/10

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

  • Drug Facts
  • Active Ingredients

    Arnica Montana 30X HPUS

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  • Purposes

    Anti-Inflammatory

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  • Uses

    Temporary relief of bruising, swelling and pain

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  • Warnings

    If you are nursing, pregnant, or taking any medications, consult your doctor before use. Discontinue use if any adverse reactions occur.

    If symptoms do not subside within 14 days, contact your physician.

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  • KEEP OUT OF REACH OF CHILDREN.

    Tamper evident: Do not use if seal is broken or shows any sign of tampering.

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  • Directions

    Begin taking Arnica Montana immediately following soft tissue injury or surgery and continue until the bruising and swelling subsides. To ensure proper absorption, do not brush your teeth, eat or drink anything but water 15 minutes before and 15 minutes after taking this product. This product is a sublingual application. Do not handle the tablets. Instead, drop tablets directly under the tongue and let dissolve naturally. Adults: 3 tablets, 3 times a day.

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  • Inactive Ingredients

    Lactose, Gum Acacia

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  • PRINCIPAL DISPLAY PANEL

    250 count label

    NDC 65111-002-74

    VitaMedica®

    Arnica
    Montana 30X HPUS

    Homeopathic Medicine to
    Reduce Bruising, Swelling & Pain
    From Soft Tissue Injury

    RECOVERY

    250 Tablets

    Warnings: Do not use if cap band is broken or missing. If you are diabetic, pregnant or breast-feeding, seek advice of your physician before using this product. If symptoms do not subside within 14 days, contact your physician.

    KEEP OUT OF REACH OF CHILDREN.

    Store at room temperature out of direct sunlight.

    Active Ingredient: (HPUS) Arnica Montana 30X.

    Made in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS)

    Indications: Unless advised otherwise by your physician: Arnica Montana provides temporary relief of bruising and swelling and the discomfort associated with surgery or soft tissue injury.

    Directions: Begin taking Arnica Montana immediately following soft tissue injury and continue until the bruising and swelling subsides (7-14 days). To ensure proper absorption, do not brush your teeth, eat or drink anything but water 15 minutes before and 15 minutes after taking this product. Do not handle the tablests. Instead, drop tablets into bottle cap and place tablets under the tongue and let dissolve naturally. Adults: 3 tablets, 3 times a day.

    VitaMedica Corporation
    Manhattan Beach, CA 90266
    Toll Free: 888-367-8605
    www.vitamedica.com

    Blister Pack Label

    ARNICA MONTANA 30X

    NDC 65111-002-01

    VitaMedica®

    The Science of Natural Health®

    Homeopathic Medicine to
    Reduce Bruising, Swelling & Pain
    From Soft Tissue Injury

    RECOVERY

    40 Tablets

    Warnings: Do not use if blister is broken. If you are diabetic, pregnant or breast-feeding, seek advice of your physician before using this product. KEEP OUT OF REACH OF CHILDREN. Store at room temperature out of direct sunlight.

    Active Ingredient: (HPUS) Arnica Montana 30X.

    Made in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS).

    Indications: Unless advised otherwise by your physician: Arnica Montana provides temporary relief of bruising and swelling associated with soft tissue injury.

    ARNICA MONTANA 30X

    Directions: Begin taking Arnica Montana just prior to or immediately following your procedure. To ensure proper absorption, do not brush your teeth, eat or drink anything but water 15 minutes before and 15 minutes after taking this product. Do not handle the tablets. Instead, drop tablets directly under the tongue and let dissolve naturally. Adults: 4 tablets, 2 times a day.

    SUSTAINABLE FORESTRY INITIATIVE

    Certified Fiber Sourcing
    www.sfiprogram.org

    VitaMedica Corporation
    Manhattan Beach, CA 90266
    Toll Free: 888-367-8605
    www.vitamedica.com

    ©VitaMedica Corporation

    Arnica Montana 30X HPUS
    Temporary Relief from Bruising, Swelling & Pain

    Arnica Montana 30X is ideal for sprains and strains from overuse or sports
    injury and following cosmetic filler injections (e.g., Radiesse, Restylane,
    Juvederm). Our convenient five-day blister pack, twice daily dosing and
    quick-dissolving soft grain tablets, make VitaMedica’s Arnica Montana
    Blister Pack the perfect choice for busy, active lifestyles.

    For information about our product line or to learn more about the dietary
    steps you can take to speed recovery after a surgical procedure or injury,
    please visit our website at www.vitamedica.com.

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  • INGREDIENTS AND APPEARANCE
    ARNICA MONTANA  
    arnica montana tablet, orally disintegrating
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65111-002
    Route of Administration SUBLINGUAL 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 1mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65111-002-74 250 in 1 BOTTLE
    2 NDC:65111-002-01 1 in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    2 40 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 12/01/1999
    Labeler - VITAMEDICA INC (808198779)
    Establishment
    Name Address ID/FEI Business Operations
    STANDARD HOMEOPATHIC 832342153 MANUFACTURE
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