Label: 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

  • 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 March 19, 2019

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  • SPL UNCLASSIFIED SECTION

  • 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% 

    Label

    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% 

  • INGREDIENTS AND APPEARANCE
    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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63776-189
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aloe (UNII: V5VD430YW9) (Aloe - UNII:V5VD430YW9) Aloe30 [kp_C]  in 1 mL
    Aluminum Oxide (UNII: LMI26O6933) (Aluminum Oxide - UNII:LMI26O6933) Aluminum Oxide200 [kp_C]  in 1 mL
    Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root30 [kp_C]  in 1 mL
    Milk Thistle (UNII: U946SH95EE) (Milk Thistle - UNII:U946SH95EE) Milk Thistle200 [kp_C]  in 1 mL
    Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN) Chelidonium Majus30 [kp_C]  in 1 mL
    Collinsonia Canadensis Root (UNII: O2630F3XDR) (Collinsonia Canadensis Root - UNII:O2630F3XDR) Collinsonia Canadensis Root30 [kp_C]  in 1 mL
    Sus Scrofa Colon (UNII: 94J255A0UC) (Sus Scrofa Colon - UNII:94J255A0UC) Sus Scrofa Colon30 [kp_C]  in 1 mL
    Bos Taurus Colon (UNII: 8PD5L21RYS) (Bos Taurus Colon - UNII:8PD5L21RYS) Bos Taurus Colon30 [kp_C]  in 1 mL
    Frangula Alnus Bark (UNII: S2D77IH61R) (Frangula Alnus Bark - UNII:S2D77IH61R) Frangula Alnus Bark30 [kp_C]  in 1 mL
    Interleukin-12 Human (UNII: 7B590791ER) (Interleukin-12 Human - UNII:7B590791ER) Interleukin-12 Human30 [kp_C]  in 1 mL
    Interferon Gamma-1a (UNII: VC9M78242P) (Interferon Gamma-1a - UNII:VC9M78242P) Interferon Gamma-1a30 [kp_C]  in 1 mL
    Potassium Carbonate (UNII: BQN1B9B9HA) (Carbonate Ion - UNII:7UJQ5OPE7D) Potassium Carbonate30 [kp_C]  in 1 mL
    Sodium Carbonate (UNII: 45P3261C7T) (Carbonate Ion - UNII:7UJQ5OPE7D) Sodium Carbonate30 [kp_C]  in 1 mL
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin30 [kp_C]  in 1 mL
    Strychnos Nux-Vomica Seed (UNII: 269XH13919) (Strychnos Nux-Vomica Seed - UNII:269XH13919) Strychnos Nux-Vomica Seed30 [kp_C]  in 1 mL
    Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid30 [kp_C]  in 1 mL
    Bos Taurus Peyer'S Patch (UNII: XB9AHC8DW1) (Bos Taurus Peyer'S Patch - UNII:XB9AHC8DW1) Bos Taurus Peyer'S Patch30 [kp_C]  in 1 mL
    Sus Scrofa Peyer'S Patch (UNII: 308LM01C72) (Sus Scrofa Peyer'S Patch - UNII:308LM01C72) Sus Scrofa Peyer'S Patch30 [kp_C]  in 1 mL
    Sus Scrofa Rectum (UNII: QV1358E70N) (Sus Scrofa Rectum - UNII:QV1358E70N) Sus Scrofa Rectum30 [kp_C]  in 1 mL
    Serotonin (UNII: 333DO1RDJY) (Serotonin - UNII:333DO1RDJY) Serotonin30 [kp_C]  in 1 mL
    Taraxacum Officinale (UNII: 39981FM375) (Taraxacum Officinale - UNII:39981FM375) Taraxacum Officinale30 [kp_C]  in 1 mL
    Thiamine (UNII: X66NSO3N35) (Thiamine Ion - UNII:4ABT0J945J) Thiamine30 [kp_C]  in 1 mL
    Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP) Vitamin D30 [kp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63776-189-111 in 1 BOX07/05/2019
    10.5 mL in 1 AMPULE; Type 0: Not a Combination Product
    2NDC:63776-189-141 in 1 BOX07/05/2019
    230 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:63776-189-151 in 1 BOX07/05/2019
    350 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    4NDC:63776-189-161 in 1 BOX07/05/2019
    4100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:63776-189-171 in 1 BOX07/05/2019
    5250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/29/2019
    Labeler - VIATREXX BIO INCORPORATED (078419880)
    Establishment
    NameAddressID/FEIBusiness Operations
    8046255 Canada Inc200651455api manufacture(63776-189) , label(63776-189) , manufacture(63776-189) , pack(63776-189)
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Importations Herbasante Inc243254612manufacture(63776-189)
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