Label: CATEGORY V- 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 V

    Adrenalinum 15X                                 Fraxinus Americana 4X                       Salicylicum Acidum 9X, 12X

    Anagallis Arvensis 3X                          Ignatia Amara 6X                                Salix Nigra 20X

    Anthemis Nobilis 10X                           Kali Carbonicum 8X                             Sarcolacticum Acidum 10X, 15X

    Arsenicum Iodatum 10X                      Murex Purpurea 14X                            Staphysagria 5X

    Calcerea Lactica 14X, 50X                   Nitromuriaticum Acidum 15X                Uranium Nitricum 17X

    Citricum Acidum 10X, 15X                    Petroselinum Sativum 12X, 20X

    Cuprum Metallicum 15X, 25X               Picricum Acidum 12X

  • Category V

    Alcohol, Purified Water

  • Category V

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

  • Category V

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

  • Category V

    For the temporary relief of general cold and flu symptoms, fever, achiness, and cough.

  • Category V

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

  • Category V

    Eases cold and flu symptoms, fever, achiness and cough.

  • Category V

    Label

  • INGREDIENTS AND APPEARANCE
    CATEGORY V 
    immune system booster liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-086
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) (PETROSELINUM CRISPUM - UNII:1WZA4Y92EX) PETROSELINUM CRISPUM20 [hp_X]  in 1 mL
    PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S) PICRIC ACID12 [hp_X]  in 1 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID12 [hp_X]  in 1 mL
    SALIX NIGRA BARK (UNII: QU52J3A5B3) (SALIX NIGRA BARK - UNII:QU52J3A5B3) SALIX NIGRA BARK20 [hp_X]  in 1 mL
    LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID15 [hp_X]  in 1 mL
    DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED5 [hp_X]  in 1 mL
    URANYL NITRATE HEXAHYDRATE (UNII: 3V057702FY) (URANIUM CATION (6+) - UNII:5PI36AS4G7) URANYL NITRATE HEXAHYDRATE17 [hp_X]  in 1 mL
    HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE (UNII: IQV54TN60Y) (HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - UNII:IQV54TN60Y) HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE14 [hp_X]  in 1 mL
    AQUA REGIA (UNII: X3TT5X989E) (AQUA REGIA - UNII:X3TT5X989E) AQUA REGIA15 [hp_X]  in 1 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER25 [hp_X]  in 1 mL
    FRAXINUS AMERICANA BARK (UNII: 0B24UR1O1S) (FRAXINUS AMERICANA BARK - UNII:0B24UR1O1S) FRAXINUS AMERICANA BARK4 [hp_X]  in 1 mL
    EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE15 [hp_X]  in 1 mL
    ANAGALLIS ARVENSIS (UNII: 46883LR90E) (ANAGALLIS ARVENSIS - UNII:46883LR90E) ANAGALLIS ARVENSIS3 [hp_X]  in 1 mL
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR) (CHAMAEMELUM NOBILE - UNII:7NF3GE7IWR) CHAMAEMELUM NOBILE20 [hp_X]  in 1 mL
    ARSENIC TRIIODIDE (UNII: 3029988O2T) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIIODIDE10 [hp_X]  in 1 mL
    CALCIUM LACTATE (UNII: 2URQ2N32W3) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM LACTATE50 [hp_X]  in 1 mL
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID15 [hp_X]  in 1 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED4 [hp_X]  in 1 mL
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE8 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-086-0259 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(64616-086)
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