Label: BRUSELIX BRUISING- vitamin c, zinc, arnica montana extract, bromelain, diosmin, rutin, citrus bioflavonoids, hesperidin methyl chalcone tablet
- NDC Code(s): 59088-003-81
- Packager: Puretek Corporation
- 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 mgOther Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (Vegetable Source), Coating (Hydroxypropyl Methylcellulose, PEG-8).
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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.
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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.
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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.
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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.
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INGREDIENTS AND APPEARANCE
BRUSELIX BRUISING
vitamin c, zinc, arnica montana extract, bromelain, diosmin, rutin, citrus bioflavonoids, hesperidin methyl chalcone tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59088-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER 50 mg STEM BROMELAIN (UNII: ZLM4P8929R) (STEM BROMELAIN - UNII:ZLM4P8929R) STEM BROMELAIN 400 mg SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 120 mg HESPERIDIN METHYLCHALCONE (UNII: 4T2GVA922X) (HESPERIDIN - UNII:E750O06Y6O) HESPERIDIN 25 mg RUTIN (UNII: 5G06TVY3R7) (RUTIN - UNII:5G06TVY3R7) RUTIN 50 mg DIOSMIN (UNII: 7QM776WJ5N) (DIOSMIN - UNII:7QM776WJ5N) DIOSMIN 200 mg HESPERIDIN (UNII: E750O06Y6O) (HESPERIDIN - UNII:E750O06Y6O) HESPERIDIN 25 mg ZINC PICOLINATE (UNII: ALO92O31SE) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10 mg Inactive Ingredients Ingredient Name Strength 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 Color brown (yellow to brown speckled) Score no score Shape CAPSULE (oblong caplet) Size 22mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59088-003-81 14 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/11/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/11/2024 Labeler - Puretek Corporation (785961046)