GDS-CALM- digestive balance liquid

GDS-Calm by

Drug Labeling and Warnings

GDS-Calm by is a Homeopathic medication manufactured, distributed, or labeled by Vitality Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

GDS-CALM 
digestive balance liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64616-092
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	7 [hp_X]  in 1 mL
CHRYSOPOGON ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z) (CHRYSOPOGON ZIZANIOIDES ROOT - UNII:37TB8LUP9Z)	CHRYSOPOGON ZIZANIOIDES ROOT	7 [hp_X]  in 1 mL
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR) (CHAMAEMELUM NOBILE - UNII:7NF3GE7IWR)	CHAMAEMELUM NOBILE	14 [hp_X]  in 1 mL
CANDIDA ALBICANS (UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC)	CANDIDA ALBICANS	14 [hp_X]  in 1 mL
HELIANTHEMUM CANADENSE (UNII: 46G3W789Q3) (HELIANTHEMUM CANADENSE - UNII:46G3W789Q3)	HELIANTHEMUM CANADENSE	8 [hp_X]  in 1 mL
SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869)	SYZYGIUM JAMBOS SEED	7 [hp_X]  in 1 mL
LILIUM LANCIFOLIUM WHOLE FLOWERING (UNII: X67Z2963PI) (LILIUM LANCIFOLIUM WHOLE FLOWERING - UNII:X67Z2963PI)	LILIUM LANCIFOLIUM WHOLE FLOWERING	15 [hp_X]  in 1 mL
VIROLA SEBIFERA RESIN (UNII: GHJ5XX5SGS) (VIROLA SEBIFERA RESIN - UNII:GHJ5XX5SGS)	VIROLA SEBIFERA RESIN	7 [hp_X]  in 1 mL
ASPIDOSPERMA QUEBRACHO-BLANCO BARK (UNII: 52B1340190) (ASPIDOSPERMA QUEBRACHO-BLANCO BARK - UNII:52B1340190)	ASPIDOSPERMA QUEBRACHO-BLANCO BARK	6 [hp_X]  in 1 mL
ROBINIA PSEUDOACACIA BARK (UNII: 7TPC058OWY) (ROBINIA PSEUDOACACIA BARK - UNII:7TPC058OWY)	ROBINIA PSEUDOACACIA BARK	7 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64616-092-02	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/17/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/17/2013

Labeler - Vitality Works, Inc. (137752817)

Registrant - Vitality Works, Inc. (137752817)

Establishment
Name	Address	ID/FEI	Business Operations
Vitality Works, Inc.		137752817	manufacture(64616-092)