Label: VIATREXX-ENZYME PLUS- amylase, cellulase, lactase, lipase, maltase, protease, sucrase spray
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Contains inactivated NDC Code(s)
NDC Code(s): 63776-142-11, 63776-142-14, 63776-142-15, 63776-142-16, view more63776-142-17 - Packager: VIATREXX BIO INCORPORATED
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Description
- Uses
- Warnings
- Dosage
- Keep this and all medicines out of reach of children.
- Inactive Ingredients
- Normal storage use.Do not use if tamper-evident seal is broken or removed.
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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 sprayProduct 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)