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

GI Distress by

Drug Labeling and Warnings

GI Distress by is a Homeopathic medication manufactured, distributed, or labeled by Deseret Biologicals, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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. In case of overdose, contact physician or Poison Control Center right away.

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

DIRECTIONS:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

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:

Demineralized Water, 25% Ethanol.

QUESTIONS:

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070 www.desbio.com

PACKAGE LABEL DISPLAY:

DESBIO

NDC: 43742-1304-1

HOMEOPATHIC

GI DISTRESS

1 FL OZ (30 ml)

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) liquid

Product 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)