Label: GDS-CALM- digestive balance 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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  • GDS-Calm

    Aesculus Hippocastanum 7X                    Eugenia Jambosa 7X

    Anatherum Muricatum 7X                         Lilium Tigrinum 15X

    Anthemis Nobilis 14X                               Myristica Sebifera 7X

    Candida Albicans 14X                              Quebracho 6X

    Cistus Canadensis 8X                              Robinia Pseudoacacia 7X

  • GDS-Calm

    Alcohol, Purified Water

  • GDS-Calm

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

  • GDS-Calm

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

  • GDS-Calm

    For the temporary relief of stomach upset, flatulence and heartburn.

  • GDS-Calm

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

  • GDS-Calm

    Digestive tract calming.

  • GDS-Calm

    Label

  • INGREDIENTS AND APPEARANCE
    GDS-CALM 
    digestive balance liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-092
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT7 [hp_X]  in 1 mL
    CHRYSOPOGON ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z) (CHRYSOPOGON ZIZANIOIDES ROOT - UNII:37TB8LUP9Z) CHRYSOPOGON ZIZANIOIDES ROOT7 [hp_X]  in 1 mL
    CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR) (CHAMAEMELUM NOBILE - UNII:7NF3GE7IWR) CHAMAEMELUM NOBILE14 [hp_X]  in 1 mL
    CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS14 [hp_X]  in 1 mL
    HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3) HELIANTHEMUM CANADENSE8 [hp_X]  in 1 mL
    SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869) SYZYGIUM JAMBOS SEED7 [hp_X]  in 1 mL
    LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI) LILIUM LANCIFOLIUM WHOLE FLOWERING15 [hp_X]  in 1 mL
    VIROLA SEBIFERA RESIN (UNII: GHJ5XX5SGS) (VIROLA SEBIFERA RESIN - UNII:GHJ5XX5SGS) VIROLA SEBIFERA RESIN7 [hp_X]  in 1 mL
    ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190) ASPIDOSPERMA QUEBRACHO-BLANCO BARK6 [hp_X]  in 1 mL
    ROBINIA PSEUDOACACIA BARK (UNII: 7TPC058OWY) (ROBINIA PSEUDOACACIA BARK - UNII:7TPC058OWY) ROBINIA PSEUDOACACIA BARK7 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-092-0259 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/17/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/17/2013
    Labeler - Vitality Works, Inc. (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-092)
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