VIATREXX-ENZYME PLUS- amylase, cellulase, lactase, lipase, maltase, protease, sucrase spray

Viatrexx-Enzyme Plus by

Drug Labeling and Warnings

Viatrexx-Enzyme Plus by is a Homeopathic medication manufactured, distributed, or labeled by VIATREXX BIO INCORPORATED, 8046255 Canada Inc, Les Importations Herbasante Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredients

 Amylase (6X, 30K & 200K), Cellulase (6X, 30K & 200K), Lactase (6X, 30K & 200K), Lipase (6X, 30K & 200K), Maltase (6X, 30K & 200K), Protease (6X, 30K & 200K), Sucrase (6X, 30K & 200K)

Purpose

• AmylaseCellulaseLactaseLipaseMaltaseProteaseSucrase: Enzyme for Starches; Enzyme for Cellulose; Enzyme for Lactose and dairy; Enzyme for Fats; Enzyme for Maltose; Enzyme for Proteins; Enzyme for Sugars

Description

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

Uses

To support healthy digestion.

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: 63776-142-11
Item: VPC0045

Viatrexx Bio Incorporated

Viatrexx- Enzyme +
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: 63776-142-14
Item: VPC0045

Viatrexx Bio Incorporated

Viatrexx-Enzyme +
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: 63776-142-15
Item: VPC0045

Viatrexx Bio Incorporated

Viatrexx-Enzyme +
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: 63776-142-16
Item: VPC0045

Viatrexx Bio Incorporated

Viatrexx-Enzyme +
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: 63776-142-17
Item: VPC0045

Viatrexx Bio Incorporated

Viatrexx-Enzyme +
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-ENZYME PLUS 
amylase, cellulase, lactase, lipase, maltase, protease, sucrase spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63776-142
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pancreatic Alpha-Amylase (UNII: CIK15T34RB) (Pancreatic Alpha-Amylase - UNII:CIK15T34RB)	Pancreatic Alpha-Amylase	30 [kp_C]  in 1 mL
Cellulase (Trichoderma Longibrachiatum) (UNII: 7Q170212NX) (Cellulase (Trichoderma Longibrachiatum) - UNII:7Q170212NX)	Cellulase (Trichoderma Longibrachiatum)	30 [kp_C]  in 1 mL
Lactase (UNII: 37515NWH9U) (Lactase - UNII:37515NWH9U)	Lactase	30 [kp_C]  in 1 mL
Pancreatic Triacylglycerol Lipase (UNII: THEA1III4L) (Pancreatic Triacylglycerol Lipase - UNII:THEA1III4L)	Pancreatic Triacylglycerol Lipase	30 [kp_C]  in 1 mL
Lysosomal Alpha-Glucosidase (UNII: S0FLU182ZW) (Lysosomal Alpha-Glucosidase - UNII:S0FLU182ZW)	Lysosomal Alpha-Glucosidase	30 [kp_C]  in 1 mL
Pancrelipase Protease (UNII: 3560D81V50) (Pancrelipase Protease - UNII:3560D81V50)	Pancrelipase Protease	30 [kp_C]  in 1 mL
Sacrosidase (UNII: 8A7F670F2Y) (Sacrosidase - UNII:8A7F670F2Y)	Sacrosidase	30 [kp_C]  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: 63776-142-11	1 in 1 BOX	07/05/2019
1		0.5 mL in 1 AMPULE; Type 0: Not a Combination Product
2	NDC: 63776-142-14	1 in 1 BOX	07/05/2019
2		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 63776-142-15	1 in 1 BOX	07/05/2019
3		50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4	NDC: 63776-142-16	1 in 1 BOX	07/05/2019
4		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 63776-142-17	1 in 1 BOX	07/05/2019
5		250 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - VIATREXX BIO INCORPORATED (078419880)

Establishment
Name	Address	ID/FEI	Business Operations
8046255 Canada Inc		200651455	api manufacture(63776-142) , label(63776-142) , manufacture(63776-142) , pack(63776-142)

Establishment
Name	Address	ID/FEI	Business Operations
Les Importations Herbasante Inc		243254612	manufacture(63776-142)