Active Ingredients

Aloe (5X, 30K), Alumina (200K), Byonia (30K), Carduus Marianus (3X, 30K), Chelidonium Majus (3X, 30K), Collinsonia Canadensis (3X, 30K), Colon (30K), Frangula (3X, 30K), IL 12 (10X, 30K), Inf-y (9X, 30K), Kalium Carbonicum (30K), Natrium Carbonicum (30K), Niacin (3X, 30K), Nux vomica (30K), Pantothenic Acid (3X, 30K), Peyer’s Patches (30K), Rectum (30K), Rheum (3X, 30K), Scatolum (30K), Serotonin (30K), Taraxacum (6X, 30K), Vitamin B1 (4X, 30K), Vitamin B13 (30K), Vitamin D (3X, 30K).

Purpose

Aloe
Alumina
Byonia
Carduus Marianus
Chelidonium Majus
Collinsonia Canadensis
Colon
Frangula
IL 12
Inf-y
Kalium Carbonicum
Natrium Carbonicum
Niacin
Nux vomica
Pantothenic Acid
Peyer’s Patches
Rectum
Rheum
Scatolum
Serotonin
Taraxacum
Vitamin B1
Vitamin B13
Vitamin D

Bowel function support
Constipation issues
Diarrhoea
Constipation
Liver bilary drainage
Hemorrhoids, constipation
Bowel function
Laxative
GI lining repair
GI lining repair
Hemorrhoids, intestinal catarrh
Diarrhoea
Lipid conversion, gut support
GI track balance, laxative
Metabolism
Immune support, Gut health
Hemorrhoids, peristaltic
Diarrhea, anal complaints
Leaky gut
Peristaltic movement
GI Drainage
GI health
GI health
GI health

Description

Viatrexx-GI is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.

Uses

To support healthy GI tract/ Bowel function and elimination.

Warnings

Stop use and ask a health care practitioner if symptoms persist for more than five days or worsen. If pregnant or breastfeeding, ask a health care practitioner before use.

Dosage

1-3 spray(s); 1-3 time(s) per day or as recommended by your health care practitioner.

Keep this and all medicines out of reach of children.

Inactive Ingredients

20% Alcohol and 80% Water

Other Information

Normal storage use.
Do not use if tamper-evident seal is broken or removed.

Product availability

Product may be acquired in 0.5, 30, 50, 100, 250 mL bottles.

References upon request

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Distributed by
Viatrexx Bio Incorporated
Newark, DE, USA, 19713

Manufactured by
8046255 Canada Inc
Beloeil, Qc, J3G 6S3

Date of last revision March 2019

For Questions and comments
Info@Viatrexx.com
www.Viatrexx.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 63776-189-11
Item: VPC0211

Viatrexx Bio Incorporated

Viatrexx-GI
Box of 1 X 0.5 mL ampule
For Oral and Topical Use

Expiry date:                          Lot #:

Manufactured for:
Viatrexx Bio Incorporated  Newark, DE, USA, 19713
www.Viatrexx.com

Ingredients, homeopathic

See insert or www.viatrexx.com

Inactives: Alcohol 20%, Water 80%

NDC: 63776-189-14
Item: VPC0211

Viatrexx Bio Incorporated

Viatrexx-GI
Box of 1 X 30 mL spray bottle
For Oral and Topical Use

Expiry date:                          Lot #:

Manufactured for:
Viatrexx Bio Incorporated  Newark, DE, USA, 19713
www.Viatrexx.com

Ingredients, homeopathic

See insert or www.viatrexx.com

Inactives: Alcohol 20%, Water 80%

NDC: 63776-189-15
Item: VPC0211

Viatrexx Bio Incorporated

Viatrexx-GI
Box of 1 X 50 mL spray bottle
For Oral and Topical Use

Expiry date:                          Lot #:

Manufactured for:
Viatrexx Bio Incorporated  Newark, DE, USA, 19713
www.Viatrexx.com

Ingredients, homeopathic

See insert or www.viatrexx.com

Inactives: Alcohol 20%, Water 80%

NDC: 63776-189-16
Item: VPC0211

Viatrexx Bio Incorporated

Viatrexx-GI
Box of 1 X 100 mL bottle
For Oral and Topical Use

Expiry date:                          Lot #:

Manufactured for:
Viatrexx Bio Incorporated  Newark, DE, USA, 19713
www.Viatrexx.com

Ingredients, homeopathic

See insert or www.viatrexx.com

Inactives: Alcohol 20%, Water 80%

NDC: 63776-189-17
Item: VPC0211

Viatrexx Bio Incorporated

Viatrexx-GI
Box of 1 X 250 mL bottle
For Oral and Topical Use

Expiry date:                          Lot #:

Manufactured for:
Viatrexx Bio Incorporated  Newark, DE, USA, 19713
www.Viatrexx.com

Ingredients, homeopathic

See insert or www.viatrexx.com

Inactives: Alcohol 20%, Water 80%

VIATREXX-GI
anti-interleukin 1, ankle articulations, beta endorphin, bfgf, calcaneal tendon, hip articulation, knee articulation, liver, transforming growth factor-1, transforming gf-beta spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63776-189
Route of Administration	ORAL, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9)	Aloe	30 [kp_C] in 1 mL
Aluminum Oxide (UNII: LMI26O6933) (Aluminum Oxide - UNII:LMI26O6933)	Aluminum Oxide	200 [kp_C] in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	30 [kp_C] in 1 mL
Milk Thistle (UNII: U946SH95EE) (Milk Thistle - UNII:U946SH95EE)	Milk Thistle	200 [kp_C] in 1 mL
Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN)	Chelidonium Majus	30 [kp_C] in 1 mL
Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR)	Collinsonia Canadensis Root	30 [kp_C] in 1 mL
Sus Scrofa Colon (UNII: 94J255A0UC) (Sus Scrofa Colon - UNII:94J255A0UC)	Sus Scrofa Colon	30 [kp_C] in 1 mL
Bos Taurus Colon (UNII: 8PD5L21RYS) (Bos Taurus Colon - UNII:8PD5L21RYS)	Bos Taurus Colon	30 [kp_C] in 1 mL
Frangula Alnus Bark (UNII: S2D77IH61R) (Frangula Alnus Bark - UNII:S2D77IH61R)	Frangula Alnus Bark	30 [kp_C] in 1 mL
Interleukin-12 Human (UNII: 7B590791ER) (Interleukin-12 Human - UNII:7B590791ER)	Interleukin-12 Human	30 [kp_C] in 1 mL
Interferon Gamma-1a (UNII: VC9M78242P) (Interferon Gamma-1a - UNII:VC9M78242P)	Interferon Gamma-1a	30 [kp_C] in 1 mL
Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D)	Potassium Carbonate	30 [kp_C] in 1 mL
Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D)	Sodium Carbonate	30 [kp_C] in 1 mL
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A)	Niacin	30 [kp_C] in 1 mL
Strychnos Nux-Vomica Seed (UNII: 269XH13919) (Strychnos Nux-Vomica Seed - UNII:269XH13919)	Strychnos Nux-Vomica Seed	30 [kp_C] in 1 mL
Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737)	Pantothenic Acid	30 [kp_C] in 1 mL
Bos Taurus Peyer'S Patch (UNII: XB9AHC8DW1) (Bos Taurus Peyer'S Patch - UNII:XB9AHC8DW1)	Bos Taurus Peyer'S Patch	30 [kp_C] in 1 mL
Sus Scrofa Peyer'S Patch (UNII: 308LM01C72) (Sus Scrofa Peyer'S Patch - UNII:308LM01C72)	Sus Scrofa Peyer'S Patch	30 [kp_C] in 1 mL
Sus Scrofa Rectum (UNII: QV1358E70N) (Sus Scrofa Rectum - UNII:QV1358E70N)	Sus Scrofa Rectum	30 [kp_C] in 1 mL
Serotonin (UNII: 333DO1RDJY) (Serotonin - UNII:333DO1RDJY)	Serotonin	30 [kp_C] in 1 mL
Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375)	Taraxacum Officinale	30 [kp_C] in 1 mL
Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	30 [kp_C] in 1 mL
Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP)	Vitamin D	30 [kp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63776-189-11	1 in 1 BOX	07/05/2019
1		0.5 mL in 1 AMPULE; Type 0: Not a Combination Product
2	NDC:63776-189-14	1 in 1 BOX	07/05/2019
2		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC:63776-189-15	1 in 1 BOX	07/05/2019
3		50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4	NDC:63776-189-16	1 in 1 BOX	07/05/2019
4		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:63776-189-17	1 in 1 BOX	07/05/2019
5		250 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/29/2019

Labeler - VIATREXX BIO INCORPORATED (078419880)

Name	Address	ID/FEI	Business Operations
Establishment
8046255 Canada Inc		200651455	api manufacture(63776-189) , label(63776-189) , manufacture(63776-189) , pack(63776-189)

Name	Address	ID/FEI	Business Operations
Establishment
Les Importations Herbasante Inc		243254612	manufacture(63776-189)

GI