Bruselix Tablets

Bruselix Tablets
SPL v1
SPL
SPL Set ID 24245e80-529f-0542-e063-6394a90a1fb4
Route
ORAL
Published
Effective Date 2024-10-10
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Flower (50 mg) Stem Bromelain (400 mg) Ascorbic Acid (120 mg) Hesperidin (25 mg) Rutin (200 mg) Diosmin (10 mg) Zinc Cation
Inactive Ingredients
Magnesium Stearate Stearic Acid Polyethylene Glycol 400 Microcrystalline Cellulose 102 Dibasic Calcium Phosphate Dihydrate Silicon Dioxide Hypromellose, Unspecified Croscarmellose Sodium

Identifiers & Packaging

Pill Appearance
Shape: capsule Color: brown Size: 22 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-10-11

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.

Dosage and Administration

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

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.

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.

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.

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.

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]


Medication Information

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.

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.

Dosage and Administration

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

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.

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.

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.

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]

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).

Label

Manufactured by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

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.

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).

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]

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.

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.

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.

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.

Dosage and Administration:

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


Structured Label Content

Label (LABEL)

Manufactured by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Overdose: (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.

Description: (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).

How Supplied: (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]

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.

Contraindications: (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.

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.

Indications and Usage: (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.

Warnings and Precautions (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.

Dosage and Administration: (DOSAGE AND ADMINISTRATION:)

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


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