Label: GI DISTRESS (echinacea (angustifolia), natrum phosphoricum, colchicum autumnale, arsenicum album, colocynthis, croton tiglium, gambogia, aceticum acidum, antimonium crudum, bismuthum subnitricum, cinchona officinalis, ferrum metallicum, iris versicolor, lac defloratum, mercurius vivus, nux vomica, ricinus communis, veratrum album, colibacillinum cum natrum muriaticum, proteus- mirabilis liquid
- NDC Code(s): 43742-1304-1
- 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 September 26, 2018
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ACTIVE INGREDIENTS:
Echinacea (Angustifolia) 3X, Natrum Phosphoricum 6X, Colchicum Autumnale 8X, Arsenicum Album 8X, 12X 30X, Colocynthis 9X, Croton Tiglium 9X, Gambogia 9X, Aceticum Acidum 12X, Antimonium Crudum 12X, Bismuthum Subnitricum 12X, Cinchona Officinalis 12X, Ferrum Metallicum 12X, Iris Versicolor 12X, Lac Defloratum 12X, Mercurius Vivus 12X, Nux Vomica 12X, Ricinus Communis 12X, Veratrum Album 12X, Colibacillinum Cum Natrum Muriaticum 16X, Proteus (Mirabilis) 16X.
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to occasional watery diarrhea, irritation of stomach, indigestion, abdominal bloating, stomach cramps, and loss of appetite.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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HOMEOPATHIC INDICATIONS:
For the temporary relief of symptoms related to occasional watery diarrhea, irritation of stomach, indigestion, abdominal bloating, stomach cramps, and loss of appetite.**
**These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
- QUESTIONS:
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INGREDIENTS AND APPEARANCE
GI DISTRESS
echinacea (angustifolia), natrum phosphoricum, colchicum autumnale, arsenicum album, colocynthis, croton tiglium, gambogia, aceticum acidum, antimonium crudum, bismuthum subnitricum, cinchona officinalis, ferrum metallicum, iris versicolor, lac defloratum, mercurius vivus, nux vomica, ricinus communis, veratrum album, colibacillinum cum natrum muriaticum, proteus (mirabilis) liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43742-1304 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA 3 [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 COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB 8 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 8 [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 GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE 9 [hp_X] in 1 mL 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 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 IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 12 [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 STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 12 [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 ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI 16 [hp_X] in 1 mL PROTEUS MIRABILIS (UNII: C177VR41DV) (PROTEUS MIRABILIS - UNII:C177VR41DV) PROTEUS MIRABILIS 16 [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:43742-1304-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/26/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/26/2018 Labeler - Deseret Biologicals, Inc. (940741853) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43742-1304) , api manufacture(43742-1304) , label(43742-1304) , pack(43742-1304)
