Label: TRIPLE COMPLEX CALM TONIC- ferrum phos, kali phos, mag phos tincture

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 3, 2013

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  • PURPOSE

    Relieves symptoms of stress, worry and nervous tension

  • ACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

    Uses:Homeopathic remedy for nervous system support

  • WARNINGS

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

  • PREGNANCY OR BREAST FEEDING

    If pregnant of breastfeeding, ask health professional before use

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children

  • OVERDOSAGE

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

  • DOSAGE & ADMINISTRATION

    Directions: For all ages: Acute: Take 0.25 mL to 0.50 mL every hour for up to 10 doses or until symptoms subside. Chronic: Take 0.25 mL to 0.50 mL 3 times daily

  • INACTIVE INGREDIENT

    Inactive Ingredients:USP Purified Water, USP Grain Alcohol (20% by volume), Lactose

  • INFORMATION FOR PATIENTS

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

    All Native Remedies health products 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: +1.1877.289.1235
    International:+1.561.999.8857

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

  • STORAGE AND HANDLING

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

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    TRIPLE COMPLEX CALM TONIC  
    ferrum phos, kali phos, mag phos tincture
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE8 [hp_X]  in 1 mL
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]  in 1 mL
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    LACTOSE (UNII: J2B2A4N98G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-054-6059 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/03/2013
    Labeler - Native Remedies, LLC (192014186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc137752817manufacture(68703-054) , api manufacture(68703-054)
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