Label: VITALIZER (echinacea- angustifolia, iodium, arsenicum album, aurum metallicum, calcarea fluorica, gallicum acidum, hekla lava, niccolum sulphuricum, phosphorus, sedum acre, sempervivum tectorum, senecio aureus, blatta americana, onosmodium virginianum liquid

  • NDC Code(s): 43857-0629-1
  • Packager: BioActive Nutritional, Inc.
  • 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 6, 2023

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  • ACTIVE INGREDIENTS:

    Echinacea 3X, Iodium 6X, Arsenicum Album 12X, Aurum Metallicum 12X, Calcarea Fluorica 12X, Gallicum Acidum 12X, Hekla Lava 12X, Niccolum Sulphuricum 12X, Phosphorus 12X, Sedum Acre 12X, Sempervivum Tectorum 12X, Senecio Aureus 12X, Blatta Americana 16X, Onosmodium Virginianum 30C.

  • PURPOSE:

    For temporary relief of fatigue, weakness after exhausting diseases, headaches and sensitivity to light and noise.

  • WARNINGS:

    If pregnant or breast-feeding, ask a health care 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 cool, dry place.

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    For temporary relief of fatigue, weakness after exhausting diseases, headaches and sensitivity to light and noise.

  • INACTIVE INGREDIENTS:

    Demineralized Water, 25% Ethanol

  • QUESTIONS:

    Distributed by:
    BioActive Nutritional, Inc.
    1803 N. Wickham Rd.
    Melbourne, FL 32935
    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActive Nutritional

    VITALIZER

    HOMEOPATHIC

    1 FL OZ (30 ml)

    VITALIZER

  • INGREDIENTS AND APPEARANCE
    VITALIZER 
    echinacea (angustifolia), iodium, arsenicum album, aurum metallicum, calcarea fluorica, gallicum acidum, hekla lava, niccolum sulphuricum, phosphorus, sedum acre, sempervivum tectorum, senecio aureus, blatta americana, onosmodium virginianum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0629
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]  in 1 mL
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE6 [hp_X]  in 1 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD12 [hp_X]  in 1 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE12 [hp_X]  in 1 mL
    GALLIC ACID MONOHYDRATE (UNII: 48339473OT) (GALLIC ACID - UNII:632XD903SP) GALLIC ACID MONOHYDRATE12 [hp_X]  in 1 mL
    HEKLA LAVA (UNII: C21158IIRK) (HEKLA LAVA - UNII:C21158IIRK) HEKLA LAVA12 [hp_X]  in 1 mL
    NICKEL SULFATE HEXAHYDRATE (UNII: JC9WZ4FK68) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL SULFATE HEXAHYDRATE12 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
    SEDUM ACRE WHOLE (UNII: 2496VW6S9J) (SEDUM ACRE - UNII:2496VW6S9J) SEDUM ACRE WHOLE12 [hp_X]  in 1 mL
    SEMPERVIVUM TECTORUM LEAF (UNII: 3DGJ7BUA01) (SEMPERVIVUM TECTORUM LEAF - UNII:3DGJ7BUA01) SEMPERVIVUM TECTORUM LEAF12 [hp_X]  in 1 mL
    PACKERA AUREA WHOLE (UNII: 5WS1632J8W) (PACKERA AUREA - UNII:5WS1632J8W) PACKERA AUREA WHOLE12 [hp_X]  in 1 mL
    PERIPLANETA AMERICANA (UNII: 2RQ1L9N089) (PERIPLANETA AMERICANA - UNII:2RQ1L9N089) PERIPLANETA AMERICANA16 [hp_X]  in 1 mL
    ONOSMODIUM VIRGINIANUM (UNII: 604NK4250S) (ONOSMODIUM VIRGINIANUM - UNII:604NK4250S) ONOSMODIUM VIRGINIANUM30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0629-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/06/2023
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0629) , api manufacture(43857-0629) , label(43857-0629) , pack(43857-0629)
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