Label: CATEGORY III- immune system booster liquid

  • 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 December 28, 2023

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  • Category III

    Arsenicum Album 10X                         Corallium Rubrum 15X

    Arsenicum Iodatum 8X                        Lecithin 10X

    Artemisea Vulagaris 7X                       Myrica Cerifera 7X

    Aurum Metallicum 10X                         Ornithogalum Umbellatum 10X

    Carbo Vegetabilis 12X                         Pertoselinum Sativum 10X

    Chionanthus Virginica 7X                    Sanguinaria Canadensis 7X

  • Category III

    Alcohol, Purified Water

  • Category III

    Use only under the direction of a health care professional. Do not use if tamper evident seal is broken or missing.

  • Category III

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

  • Category III

    For the temporary relief of headaches, malaise, fever, digestive upset and discomfort, sleeplessness and general unrest.

  • Category III

    Orally 25 drops, per day or as indicated by a physician. Children 12 and under use one half the adult dosage.

  • Category III

    Temporarely eases headaches, malaise, fever, digestive upset and discomfort, sleeplessness and general unrest.

  • Category III

    Label

  • INGREDIENTS AND APPEARANCE
    CATEGORY III 
    immune system booster liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-084
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE10 [hp_X]  in 1 mL
    ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE10 [hp_X]  in 1 mL
    ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S) (ARTEMISIA VULGARIS ROOT - UNII:32MP823R8S) ARTEMISIA VULGARIS ROOT9 [hp_X]  in 1 mL
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD10 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 1 mL
    CHIONANTHUS VIRGINICUS BARK (UNII: S9Y4B22U2E) (CHIONANTHUS VIRGINICUS BARK - UNII:S9Y4B22U2E) CHIONANTHUS VIRGINICUS BARK7 [hp_X]  in 1 mL
    CORALLIUM RUBRUM EXOSKELETON (UNII: 2CA71K0DLE) (CORALLIUM RUBRUM EXOSKELETON - UNII:2CA71K0DLE) CORALLIUM RUBRUM EXOSKELETON15 [hp_X]  in 1 mL
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV) (EGG PHOSPHOLIPIDS - UNII:1Z74184RGV) EGG PHOSPHOLIPIDS15 [hp_X]  in 1 mL
    MORELLA CERIFERA ROOT BARK (UNII: S46HJ3710D) (MORELLA CERIFERA ROOT BARK - UNII:S46HJ3710D) MORELLA CERIFERA ROOT BARK7 [hp_X]  in 1 mL
    ORNITHOGALUM UMBELLATUM (UNII: 9NS3M2Y78S) (ORNITHOGALUM UMBELLATUM - UNII:9NS3M2Y78S) ORNITHOGALUM UMBELLATUM10 [hp_X]  in 1 mL
    PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM10 [hp_X]  in 1 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT10 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-084-0259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/20/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/13/2013
    Labeler - Vitality Works, Inc. (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-084)