GDS-CALM- digestive balance liquid 
Vitality Works, Inc.

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.

----------

GDS-Calm

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

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)

Revised: 12/2023
Document Id: 0d9b8bfc-62d3-3e8f-e063-6294a90a373b
Set id: 138bfd5e-6586-4fec-bd77-469bad10d1da
Version: 6
Effective Time: 20231228
 
Vitality Works, Inc.