Bruselix Bruising Tablet
FDA Label NDC 59088-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Bruselix Bruising (NDC 59088-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description:, indications and usage:, contraindications:, warnings and precautions, drug interactions:, adverse reactions:, overdose:, dosage and administration:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Description:

→ Indications And Usage:

→ Contraindications:

→ Warnings And Precautions

→ Drug Interactions:

→ Adverse Reactions:

→ Overdose:

→ Dosage And Administration:

→ How Supplied:

→ Label

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 (Untitled)

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