GABA- gamma.-aminobutyric acid spray

GABA by

Drug Labeling and Warnings

GABA 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]

Active Ingredients

Gamma-Amino Butyric Acid (6X, 200K).

Purpose:

• Gamma-Amino Butyric Acid: Neurological support

Description

Viatrexx- GABA 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 help with the support of health aging & vigor.

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.

Product Availability 

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

Inactive Ingredients

20% Alcohol and 80% Water

Other Information

Normal storage use.

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

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: 63776-690-11
Item: VPC0070

Viatrexx Bio Incorporated

Viatrexx- GABA
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: 63776-690-14
Item: VPC0070

Viatrexx Bio Incorporated

Viatrexx- GABA 
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: 63776-690-15
Item: VPC0070

Viatrexx Bio Incorporated

Viatrexx- GABA 
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: 63776-690-16
Item: VPC0070

Viatrexx Bio Incorporated

Viatrexx- GABA 
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: 63776-690-17
Item: VPC0070

Viatrexx Bio Incorporated

Viatrexx- GABA
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

GABA 
gamma.-aminobutyric acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63776-690
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.Gamma.-Aminobutyric Acid (UNII: 2ACZ6IPC6I) (.Gamma.-Aminobutyric Acid - UNII:2ACZ6IPC6I)	.Gamma.-Aminobutyric Acid	200 [kp_C]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63776-690-11	1 in 1 BOX	08/21/2019
1		0.5 mL in 1 AMPULE; Type 0: Not a Combination Product
2	NDC: 63776-690-14	1 in 1 BOX	08/21/2019
2		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
3	NDC: 63776-690-15	1 in 1 BOX	08/21/2019
3		50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
4	NDC: 63776-690-16	1 in 1 BOX	08/21/2019
4		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 63776-690-17	1 in 1 BOX	08/21/2019
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		07/24/2012

Labeler - VIATREXX BIO INCORPORATED (078419880)

Establishment
Name	Address	ID/FEI	Business Operations
8046255 Canada Inc		200651455	api manufacture(63776-690) , label(63776-690) , manufacture(63776-690) , pack(63776-690)

Establishment
Name	Address	ID/FEI	Business Operations
Les Importations Herbasante Inc		243254612	manufacture(63776-690)