VIATREXX- SINISTER 7- corn, eggs, milk, soy, sugar, wheat, yeast spray

Viatrexx- Sinister 7 by

Drug Labeling and Warnings

Viatrexx- Sinister 7 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

Corn (15X, 30K & 200K), Eggs (15X, 30K & 200K), Milk (15X, 30K & 200K), Soy (15X, 30K & 200K), Sugar (15X, 30K & 200K), Wheat (15X, 30K & 200K), Yeast (15X, 30K & 200K)

Purpose

• CornEggsMilkSoySugarWheatYeast: Corn sensitivities; Egg sensitivities; Milk sensitivities; Soy sensitivities; Sugar sensitivities; Wheat sensitivities; Yeast sensitivities

Description

Viatrexx- Sinister 7 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

For sensitivities to common foods.

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: 63776-484-11
Item: VPC0650

Viatrexx Bio Incorporated

Viatrexx- Sinister 7
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: 63776-484-14
Item: VPC0650

Viatrexx Bio Incorporated

Viatrexx-Sinister 7
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: 63776-484-15
Item: VPC0650

Viatrexx Bio Incorporated

Viatrexx-Sinister 7
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: 63776-484-16
Item: VPC0650

Viatrexx Bio Incorporated

Viatrexx-Sinister 7
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: 63776-484-17
Item: VPC0650

Viatrexx Bio Incorporated

Viatrexx-Sinister 7
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- SINISTER 7 
corn, eggs, milk, soy, sugar, wheat, yeast spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63776-484
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Corn (UNII: 0N8672707O) (Corn - UNII:0N8672707O)	Corn	30 [kp_C]  in 1 mL
Egg (UNII: 291P45F896) (Egg - UNII:291P45F896)	Egg	30 [kp_C]  in 1 mL
Cow Milk (UNII: 917J3173FT) (Cow Milk - UNII:917J3173FT)	Cow Milk	30 [kp_C]  in 1 mL
Soy Protein (UNII: R44IWB3RN5) (Soy Protein - UNII:R44IWB3RN5)	Soy Protein	30 [kp_C]  in 1 mL
Sucrose (UNII: C151H8M554) (Sucrose - UNII:C151H8M554)	Sucrose	30 [kp_C]  in 1 mL
Wheat (UNII: 4J2I0SN84Y) (Wheat - UNII:4J2I0SN84Y)	Wheat	30 [kp_C]  in 1 mL
Yeast, Unspecified (UNII: 3NY3SM6B8U) (Yeast, Unspecified - UNII:3NY3SM6B8U)	Yeast, Unspecified	30 [hp_X]  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: 63776-484-11	1 in 1 BOX	07/05/2019
1		0.5 mL in 1 AMPULE; Type 0: Not a Combination Product
2	NDC: 63776-484-14	1 in 1 BOX	07/05/2019
2		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 63776-484-15	1 in 1 BOX	07/05/2019
3		50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4	NDC: 63776-484-16	1 in 1 BOX	07/05/2019
4		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 63776-484-17	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(63776-484) , label(63776-484) , manufacture(63776-484) , pack(63776-484)

Establishment
Name	Address	ID/FEI	Business Operations
Les Importations Herbasante Inc		243254612	manufacture(63776-484)