Label: GASTROTONE (gentiana lutea, sambucus nigra, arsenicum album, kali bichromicum, lycopodium clavatum, phosphorus, pulsatilla- vulgaris, bismuthum subnitricum liquid
- NDC Code(s): 44911-0455-1
- Packager: Energique, Inc.
- Category: HUMAN OTC DRUG LABEL
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 March 17, 2022
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- ACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
GASTROTONE
gentiana lutea, sambucus nigra, arsenicum album, kali bichromicum, lycopodium clavatum, phosphorus, pulsatilla (vulgaris), bismuthum subnitricum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0455 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT 3 [hp_X] in 1 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 3 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 12 [hp_X] in 1 mL POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 12 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 12 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 12 [hp_X] in 1 mL BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE 15 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0455-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/08/2018 11/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/08/2018 11/03/2025 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0455) , api manufacture(44911-0455) , label(44911-0455) , pack(44911-0455)