Label: CATEGORY IV- 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 IV

    Actaea Spicata 6X                                    Dulcamara 5X

    Aloe Socotrina 7X                                     Fraxinus Americana 8X

    Cantharis 7X                                            La Defloratum 12X, 20X

    Cuprum Arsenicosum 15X                        Urtica Urens 5X

    Cuprum Metallicum 10X                           Zinc Metallicum 10X, 20X

  • Category IV

    Alcohol, Purified Water

  • Category IV

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

  • Category IV

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

  • Category IV

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

  • Category IV

    Orally 25 drops, 2 times per day or as indicated by a physician. Children 12 and under use one half the adult dosage.

  • Category IV

    Temporarly relieves headaches, malaise, fever, digestive upset and discomfort, sleeplessness and general unrest.

  • Category IV

    Label

  • INGREDIENTS AND APPEARANCE
    CATEGORY IV 
    immune system booster liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-085
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0) ACTAEA SPICATA ROOT6 [hp_X]  in 1 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE7 [hp_X]  in 1 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA7 [hp_X]  in 1 mL
    CUPRIC ARSENITE (UNII: SK8L60BCSQ) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ARSENITE15 [hp_X]  in 1 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER10 [hp_X]  in 1 mL
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP5 [hp_X]  in 1 mL
    SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK20 [hp_X]  in 1 mL
    FRAXINUS AMERICANA BARK (UNII: 0B24UR1O1S) (FRAXINUS AMERICANA BARK - UNII:0B24UR1O1S) FRAXINUS AMERICANA BARK8 [hp_X]  in 1 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS5 [hp_X]  in 1 mL
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC20 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-085-0259 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 homeopathic03/20/2013
    Labeler - Vitality Works, Inc. (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-085)
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