Label: TRIPLE COMPLEX UT TONIC - ferrosoferric phosphate, potassium sulfate and sodium phosphate, dibasic, heptahydrate tincture

  • 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 04/13

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

  • PURPOSE

    Relieves burning sensation, frequent urination and urgency

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  • ACTIVE INGREDIENT

    Active Ingredients: Each dose contains equal parts of Ferrum phos 8X HPUS, Kali sulph 6X HPUS, Nat phos 6X HPUS

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  • INDICATIONS & USAGE

    Uses: Homeopathic remedy for relieving the symptoms of bladder problems

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  • WARNINGS

    Warnings: If symptoms persist or worsen, consult a health professional

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  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use

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  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children

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  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away

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  • DOSAGE & ADMINISTRATION

    Directions: Babies and children: Take 0.25 mL 3-6 times daily depending on need. Adults: Take 0.50 ml 3-6 times daily. Maintenance serving: Repeat above serving 2-3 times daily

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  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified water, USP grain alcohol (20% by volume), Lactose

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  • INFORMATION FOR PATIENTS

    The letters HPUS indicate that the component in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

    All Native Remedies health product are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com

    Distributed by
    Native Remedies, LLC
    6531 Park of Commerce Blvd.
    Suite 160
    Boca Raton, Fl 33487
    Phone: +1.877.289.1235
    International:+1.561.999.8857

    Contains no animal products, gluten, artificial flavors, preservatives or colorants

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  • STORAGE AND HANDLING

    Tamper resistant for your protection. Use only if safety seal is intact

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  • INGREDIENTS AND APPEARANCE
    TRIPLE COMPLEX UT TONIC 
    ferrum phos, kali sulp, nat phos tincture
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68703-072
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROSOFERRIC PHOSPHATE (FERROSOFERRIC PHOSPHATE) FERROSOFERRIC PHOSPHATE 8 [hp_X]  in 1 mL
    POTASSIUM SULFATE (SULFATE ION) POTASSIUM SULFATE 6 [hp_X]  in 1 mL
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (PHOSPHATE ION) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    LACTOSE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68703-072-59 59 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 04/24/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    Name Address ID/FEI Business Operations
    Vitality Works, Inc 137752817 manufacture(68703-072), api manufacture(68703-072)
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