Label: GI DISTRESS (aceticum acidum, antimonium crudum, arsenicum album, bismuthum subnitricum, cinchona officinalis, colchicum autumnale, colibacillinum cum natrum muriaticum, colocynthis, croton tiglium, echinacea (angustifolia), ferrum metallicum, gambogia, iris versicolor, lac defloratum, mercurius vivus, natrum phosphoricum, nux vomica, proteus- mirabilis, ricinus communis, veratrum album liquid
- NDC Code(s): 43742-2179-1
- Packager: Deseret Biologicals, Inc.
- 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 May 13, 2024
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ACTIVE INGREDIENT:
Aceticum Acidum 12X, Antimonium Crudum 12X, Arsenicum Album 8X, 12X, 30X, Bismuthum Subnitricum 12X, Cinchona Officinalis 12X, Colchicum Autumnale 8X, Colibacillinum Cum Natrum Muriaticum 16X, Colocynthis 9X, Croton Tiglium 9X, Echinacea (Angustifolia) 3X, Ferrum Metallicum 12X, Gambogia 9X, Iris Versicolor 12X, Lac Defloratum 12X, Mercurius Vivus 12X, Natrum Phosphoricum 6X, Nux Vomica 12X, Proteus (Mirabilis) 20X, Ricinus Communis 12X, Veratrum Album 12X.
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PURPOSE:
Aceticum Acidum - Indigestion, Antimonium Crudum – Occasional Diarrhea, Arsenicum Album – Stomach Irritation, Bismuthum Subnitricum - Indigestion, Cinchona Officinalis – Abdominal Bloating, Colchicum Autumnale – Stomach Cramps, Colibacillinum Cum Natrum Muriaticum – Abdominal Bloating, Colocynthis - Indigestion, Croton Tiglium – Occasional Diarrhea, Echinacea (Angustifolia) – Loss of Appetite, Ferrum Metallicum - Indigestion, Gambogia – Abdominal Bloating, Iris Versicolor – Stomach Cramping, Lac Defloratum – Loss of Appetite, Mercurius Vivus - Indigestion, Natrum Phosphoricum – Occasional Diarrhea, Nux Vomica – Stomach Irritation, Proteus (Mirabilis) – Stomach Irritation, Ricinus Communis – Abdominal Bloating, Veratrum Album – Stomach Cramps
- USES:
- WARNINGS:
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- DIRECTIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
GI DISTRESS
aceticum acidum, antimonium crudum, arsenicum album, bismuthum subnitricum, cinchona officinalis, colchicum autumnale, colibacillinum cum natrum muriaticum, colocynthis, croton tiglium, echinacea (angustifolia), ferrum metallicum, gambogia, iris versicolor, lac defloratum, mercurius vivus, natrum phosphoricum, nux vomica, proteus (mirabilis), ricinus communis, veratrum album liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-2179 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID 12 [hp_X] in 1 mL ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 12 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 8 [hp_X] in 1 mL BISMUTH SUBNITRATE (UNII: H19J064BA5) (BISMUTH CATION - UNII:ZS9CD1I8YE) BISMUTH SUBNITRATE 12 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 12 [hp_X] in 1 mL COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB 8 [hp_X] in 1 mL ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI 16 [hp_X] in 1 mL CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 9 [hp_X] in 1 mL CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED 9 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 3 [hp_X] in 1 mL IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 12 [hp_X] in 1 mL GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE 9 [hp_X] in 1 mL IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC) IRIS VERSICOLOR ROOT 12 [hp_X] in 1 mL SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK 12 [hp_X] in 1 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 12 [hp_X] in 1 mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 6 [hp_X] in 1 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 12 [hp_X] in 1 mL PROTEUS MIRABILIS (UNII: C177VR41DV) (PROTEUS MIRABILIS - UNII:C177VR41DV) PROTEUS MIRABILIS 20 [hp_X] in 1 mL RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX) (RICINUS COMMUNIS SEED - UNII:7EK4SFN1TX) RICINUS COMMUNIS SEED 12 [hp_X] in 1 mL VERATRUM ALBUM ROOT (UNII: QNS6W5US1Z) (VERATRUM ALBUM ROOT - UNII:QNS6W5US1Z) VERATRUM ALBUM ROOT 12 [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:43742-2179-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/13/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/13/2024 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-2179) , api manufacture(43742-2179) , label(43742-2179) , pack(43742-2179)
