INTESTINAL DISTRESS- echinacea (angustifolia), colchicum autumnale, aloe, colocynthis, mercurius corrosivus, nux vomica, arsenicum album, clostridium difficile, chininum sulphuricum, cholera nosode, campylobacter jejuni, colibacillinum cum natrum muriaticum, helicobacter pylori, shigella, yersinia enterocolitica, clostridium botulinum, salmonella typhi nosode 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 INGREDIENTS:

ECHINACEA (ANGUSTIFOLIA) 3X,  COLCHICUM AUTUMNALE 4X,  ALOE 6X,  COLOCYNTHIS 6X,  MERCURIUS CORROSIVUS 6X,  NUX VOMICA 6X,  ARSENICUM ALBUM 6X, 12X, 30X,  CLOSTRIDIUM DIFFICILE 8X, 12X, 30X,  CHININUM SULPHURICUM 12X,  CHOLERA NOSODE 12X, 30X,  CAMPYLOBACTER JEJUNI 30X,  COLIBACILLINUM CUM NATRUM MURIATICUM 30X,  HELICOBACTER PYLORI 30X,  SHIGELLA 30X,  YERSINIA ENTEROCOLITICA 30X,  CLOSTRIDIUM BOTULINUM 30X, 60X,  SALMONELLA TYPHI NOSODE 33X

INDICATIONS:

For temporary relief of symptoms related to gastronenteritis including diarrhea, stomach cramps, nausea, vomiting, fluid and electrolyte depletion, flatulence and bloating.

WARNINGS:

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

If pregnant or breast-feeding, seek advice of 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 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.

INDICATIONS:

For temporary relief of symptoms related to gastronenteritis including diarrhea, stomach cramps, nausea, vomiting, fluid and electrolyte depletion, flatulence and bloating.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Dist by: Deseret Biologicals, Inc.

469 Parkland Drive

Sandy, UT 84070

www.desbio.com

PACKAGE LABLE DISPLAY:

DESBIO

NDC 43742-0486-1

HOMEOPATHIC

INTESTINAL DISTRESS

1 FL OZ (30 ml)

INTESTINAL DISTRESS

INTESTINAL DISTRESS 
echinacea (angustifolia), colchicum autumnale, aloe, colocynthis, mercurius corrosivus, nux vomica, arsenicum album, clostridium difficile, chininum sulphuricum, cholera nosode, campylobacter jejuni, colibacillinum cum natrum muriaticum, helicobacter pylori, shigella, yersinia enterocolitica, clostridium botulinum, salmonella typhi nosode liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43742-0486
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]  in 1 mL
COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB4 [hp_X]  in 1 mL
ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE6 [hp_X]  in 1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP6 [hp_X]  in 1 mL
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42) MERCURIC CHLORIDE6 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_X]  in 1 mL
CLOSTRIDIUM DIFFICILE (UNII: PJX89V9R6N) (CLOSTRIDIUM DIFFICILE - UNII:PJX89V9R6N) CLOSTRIDIUM DIFFICILE8 [hp_X]  in 1 mL
QUININE SULFATE (UNII: KF7Z0E0Q2B) (QUININE - UNII:A7V27PHC7A) QUININE SULFATE12 [hp_X]  in 1 mL
VIBRIO CHOLERAE (UNII: 4M0784008H) (VIBRIO CHOLERAE - UNII:4M0784008H) VIBRIO CHOLERAE12 [hp_X]  in 1 mL
CAMPYLOBACTER JEJUNI (UNII: 5U38E02853) (CAMPYLOBACTER JEJUNI - UNII:5U38E02853) CAMPYLOBACTER JEJUNI30 [hp_X]  in 1 mL
ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI30 [hp_X]  in 1 mL
HELICOBACTER PYLORI (UNII: U09W5JOL3Z) (HELICOBACTER PYLORI - UNII:U09W5JOL3Z) HELICOBACTER PYLORI30 [hp_X]  in 1 mL
SHIGELLA DYSENTERIAE (UNII: 1EP6R5562J) (SHIGELLA DYSENTERIAE - UNII:1EP6R5562J) SHIGELLA DYSENTERIAE30 [hp_X]  in 1 mL
YERSINIA ENTEROCOLITICA (UNII: AUL7Y5Z806) (YERSINIA ENTEROCOLITICA - UNII:AUL7Y5Z806) YERSINIA ENTEROCOLITICA30 [hp_X]  in 1 mL
BOTULINUM TOXIN TYPE A (UNII: E211KPY694) (ABOBOTULINUMTOXINA - UNII:E211KPY694) BOTULINUM TOXIN TYPE A30 [hp_X]  in 1 mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI (UNII: 760T5R8B3O) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - UNII:760T5R8B3O) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI33 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43742-0486-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/26/201405/21/2020
Labeler - Deseret Biologicals, Inc. (940741853)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43742-0486) , api manufacture(43742-0486) , label(43742-0486) , pack(43742-0486)

Revised: 9/2015
Document Id: 1f6b1c4a-a2de-4fab-9ef2-051898cbfb23
Set id: ca36e1f5-1b23-4a6d-a4be-bce600fd8533
Version: 2
Effective Time: 20150930
 
Deseret Biologicals, Inc.