GABA- gaba (gamma-aminobutyric acid) liquid 
BioActive Nutritional, Inc.

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.

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Drug Facts:

ACTIVE INGREDIENT:

GABA (Gamma-Aminobutyric Acid) 6X, 12X, 30X, 12C, 30C.

INDICATIONS:

For temporary relief of anxiety, irritability, anger and hostility.

WARNINGS:

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of anxiety, irritability, anger and hostility.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

GABA

HOMEOPATHIC

1 FL OZ (30 ml)

GABA

GABA 
gaba (gamma-aminobutyric acid) liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0123
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I) (.GAMMA.-AMINOBUTYRIC ACID - UNII:2ACZ6IPC6I) .GAMMA.-AMINOBUTYRIC ACID 6 [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:43857-0123-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/16/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/03/2014
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
Name Address ID/FEI Business Operations
Apotheca Company 844330915 manufacture(43857-0123) , api manufacture(43857-0123) , label(43857-0123) , pack(43857-0123)

Revised: 8/2016
Document Id: 24c12661-ff0c-40a0-a64e-038e1e0a491c
Set id: 4fe29a89-c4d6-446c-b5f7-692762c58614
Version: 3
Effective Time: 20160817
 
BioActive Nutritional, Inc.