SYSTEMISTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA O

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  • SYSTEMISTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA O

SYSTEMISTAT (BERBERIS VULGARIS, CHELIDONIUM MAJUS, LAPPA MAJOR, HYDRASTIS CANADENSIS, HEPAR SULPHURIS CALCAREUM, LYCOPODIUM CLAVATUM, SULPHUR, CALCAREA CARBONICA, MERCURIUS SOLUBILIS, THUJA O
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NDC 44911-0449-1
Set ID 0d8aa575-3fae-4828-8827-d2561672a91e
Category HUMAN OTC DRUG LABEL
Packager Energique, Inc.
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENTS:

    Berberis Vulgaris 3X, Chelidonium Majus 3X,  Lappa Major 3X, Hydrastis Canadensis 5X, Hepar Sulphuris Calcareum 12X, Lycopodium Clavatum 12X, Sulphur 12X, Calcarea Carbonica 30X, Mercurius Solubilis 30X, Thuja Occidentalis 30X.

  • INDICATIONS:

    May temporarily relieve painless, clay colored diarrhea, eczema with itching, and burning hay fever with offensive discharge running from the nose.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

    Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    May temporarily relieve painless, clay colored diarrhea, eczema with itching, and burning hay fever with offensive discharge running from the nose.**

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INACTIVE INGREDIENTS:

    Demineralized water, 20% Ethanol

  • QUESTIONS:

    Dist. by Energique, Inc.
    201 Apple Blvd
    Woodbine, IA 51579 800.869.8078

  • PACKAGE LABEL DISPLAY:

    ENERGIQUE

    SINCE 1987

    HOMEPATHIC REMEDY

    SYSTEMISTAT

    1 fl. oz. (30 ml)

    Systemistat

  • INGREDIENTS AND APPEARANCE
    SYSTEMISTAT 
    berberis vulgaris, chelidonium majus, lappa major, hydrastis canadensis, hepar sulphuris calcareum, lycopodium clavatum, sulphur, calcarea carbonica, mercurius solubilis, thuja occidentalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44911-0449
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK3 [hp_X]  in 1 mL
    CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS3 [hp_X]  in 1 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT3 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL5 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE30 [hp_X]  in 1 mL
    MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS30 [hp_X]  in 1 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44911-0449-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/06/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/06/2018
    Labeler - Energique, Inc. (789886132)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(44911-0449, 44911-0449) , api manufacture(44911-0449) , pack(44911-0449)
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