Label: BRUSELIX BRUISING- vitamin c, zinc, arnica montana extract, bromelain, diosmin, rutin, citrus bioflavonoids, hesperidin methyl chalcone tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 11, 2024

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  • DESCRIPTION:

    Active Ingredients
    Each tablet contains:

    Vitamin C (as Sodium Ascorbate) ...............................................................120 mg
    Zinc (as Zinc Picolinate) ...............................................................................10 mg
    Arnica Montana Extract 10:1 (equivalent to 500 mg Arnica Montana Powder) ...50 mg
    Bromelain 2400 GDU/g (from Pineapple) ...................................................400 mg
    Diosmin (Citrus Aurantium) Fruit Extract.....................................................200 mg
    Rutin (Sophora Japonica) Flower Extract......................................................50 mg
    Citrus Bioflavonoids (from pulp and peel of lemon, orange, quince) ............25 mg
    Hesperidin Methyl Chalcone..........................................................................25 mg

    Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (Vegetable Source), Coating (Hydroxypropyl Methylcellulose, PEG-8).

  • INDICATIONS AND USAGE:

    Bruselix™ Bruising Tablets are formulated to provide nutritional support during the body’s natural recovery process. They may be helpful for individuals experiencing bruising due to minor injuries, surgical procedures, or sensitive skin. The formula contains antioxidants, enzymes, and natural extracts that are traditionally used to support overall skin health and recovery.

  • CONTRAINDICATIONS:

    Do not use if you have a known allergy to any of the ingredients in Bruselix™ Bruising Tablets, including Arnica Montana or pineapple (Bromelain). Avoid use if you have an allergy to citrus or bioflavonoid components.

  • WARNINGS AND PRECAUTIONS

    Arnica: May cause allergic reactions in sensitive individuals, especially if there is a history of ragweed allergies.

    Bromelain: May increase the risk of bleeding in individuals taking anticoagulants or antiplatelet medications. Discontinue use two weeks before surgery.

    Zinc and Vitamin C: Use cautiously in individuals with kidney disease or those prone to kidney stones. If you experience an allergic reaction or prolonged bleeding, discontinue use and seek medical attention immediately.

    For use on the order of a licensed healthcare practitioner.

    Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873.

  • Drug Interactions:

    The use of anticoagulants, such as warfarin or aspirin, may increase the risk of bleeding when combined with Bromelain. High doses of zinc can interfere with the absorption of iron when taken alongside iron supplements. Additionally, citrus bioflavonoids have the potential to enhance the effects of blood pressure-lowering medications.

  • Adverse Reactions:

    Adverse reactions associated with the use of Bruising Tablets may include mild gastrointestinal discomfort, nausea, or allergic reactions such as skin rash. In rare cases, more serious reactions, such as prolonged bleeding or hypersensitivity reactions (e.g., difficulty breathing, swelling), may occur. If you experience any serious adverse effects, discontinue use and seek medical attention immediately.

  • OVERDOSE:

    In the event of overdose, seek medical attention immediately. Symptoms of overdose may include gastrointestinal upset, nausea, or an increased risk of bleeding due to excess Bromelain.

  • DOSAGE AND ADMINISTRATION:

    Take one (1) Bruselix™ Bruising Tablets daily, or as directed by a licensed healthcare practitioner. Do not exceed recommended dose.

  • HOW SUPPLIED:

    Bruselix™ Bruising Tablets are yellow to brown speckled, clear-coated tablets, packaged in a bottle containing 14 tablets – NDC 59088-003-81.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]

  • LABEL

    Manufactured by:
    PureTek Corporation

    Panorama City, CA 91402
    For questions or information
    call toll-free: 877-921-7873

    Label

  • INGREDIENTS AND APPEARANCE
    BRUSELIX BRUISING 
    vitamin c, zinc, arnica montana extract, bromelain, diosmin, rutin, citrus bioflavonoids, hesperidin methyl chalcone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:59088-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER50 mg
    STEM BROMELAIN (UNII: ZLM4P8929R) (STEM BROMELAIN - UNII:ZLM4P8929R) STEM BROMELAIN400 mg
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
    HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X) (HESPERIDIN - UNII:E750O06Y6O) HESPERIDIN25 mg
    RUTIN (UNII: 5G06TVY3R7) (RUTIN - UNII:5G06TVY3R7) RUTIN50 mg
    DIOSMIN (UNII: 7QM776WJ5N) (DIOSMIN - UNII:7QM776WJ5N) DIOSMIN200 mg
    HESPERIDIN (UNII: E750O06Y6O) (HESPERIDIN - UNII:E750O06Y6O) HESPERIDIN25 mg
    ZINC PICOLINATE (UNII: ALO92O31SE) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    Colorbrown (yellow to brown speckled) Scoreno score
    ShapeCAPSULE (oblong caplet) Size22mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-003-8114 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/11/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/11/2024
    Labeler - Puretek Corporation (785961046)