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

  • 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 June 20, 2011

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  • ACTIVE INGREDIENT

    Ingredients: Each dose contains equal parts of biochemic tissue salts: Ferrum phos (6X) (HPUS), Kali phos (6X) (HPUS), Mag phos (6X) (HPUS)
  • PURPOSE

    Relieves symptoms of stress, worry and nervous tension

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines from the reach of children.

  • INDICATIONS & USAGE

    Indications: Homeopathic remedy for nervous system support.

  • WARNINGS

    Caution: If symptoms persist or worsen, a health care professional should be consulted

    If pregnant or breastfeeding, ask a health professional before use.

    Contains no gluten, artificial flavors, colors or preservatives

    Safe for all ages and during pregnancy.


  • DOSAGE & ADMINISTRATION

    Dosage: Acute: Chew or dissolve 2-4 tablets in the mouth every hour for up to 10 doses or until symptoms subside.

    Chronic: 2-4 tablets 3 times daily.

  • INACTIVE INGREDIENT

    Lactose (inactive ingredient).
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medicines from the reach of children.

  • INFORMATION FOR PATIENTS

    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: 1.877.289.1235

    International: + 1.561.999.8857

    The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PRINCIPAL DISPLAY PANEL

    Bottle label
  • INGREDIENTS AND APPEARANCE
    TRIPLE COMPLEX CALM TONIC 
    ferrum phos , kali phos, mag phos tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68647-207
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERRUM PHOSPHORICUM - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM6 [hp_X]
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (POTASSIUM CATION - UNII:295O53K152) POTASSIUM PHOSPHATE, DIBASIC6 [hp_X]
    MAGNESIUM PHOSPHATE (UNII: 453COF7817) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    Colorwhite (white lactose tablets) Scoreno score
    ShapeROUND (round white lactose tablets) Size5mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68647-207-10125 in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/20/2011
    Labeler - Feelgood Health (538418296)
    Establishment
    NameAddressID/FEIBusiness Operations
    W. Last567284153manufacture
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