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
Deseret Biologicals, Inc.

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.

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DRUG FACTS:

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.

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:

• For the temporary relief of symptoms including:

• occasional diarrhea • stomach cramps

• abdominal bloating • indigestion • loss of appetite

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

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

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

Tamper Evident: Sealed for your protection. Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

In case of overdose, contact a 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.

INACTIVE INGREDIENTS:

Demineralized water, 25% ethanol

QUESTIONS:

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

www.desbio.com

800-827-8204

PACKAGE LABEL DISPLAY:

DesBio

GI Distress

Homeopathic

NDC 43742-2179-1

1 FL OZ (30 ml)

GI Distress

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43742-2179
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43742-2179-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/13/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/13/2024

Labeler - Deseret Biologicals, Inc. (940741853)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43742-2179) , api manufacture(43742-2179) , label(43742-2179) , pack(43742-2179)

Revised: 5/2024

Document Id: db1968eb-3798-4005-920f-137f1846f554

Set id: 40df69fa-92ae-4f26-8664-36955cf395c5

Version: 1

Effective Time: 20240513

Deseret Biologicals, Inc.