GABA- gaba liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
.GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I) (.GAMMA.-AMINOBUTYRIC ACID - UNII:2ACZ6IPC6I)
Available from:
BioActive Nutritional, Inc.
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
For temporary relief of anxiety, irritability, anger, and hostility. For temporary relief of anxiety, irritability, anger, and hostility.
Authorization status:
unapproved homeopathic
Authorization number:
43857-0149-1

GABA- gaba 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 INGREDIENTS:

Gaba 6X.

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 6X

HOMEOPATHIC

1 FL OZ (30 ml)

GABA

gaba liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:438 57-0 149

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

.GAMMA.-AMINO BUTYRIC ACID (UNII: 2ACZ6 IPC6 I) (.GAMMA.-AMINOBUTYRIC ACID

- UNII:2ACZ6 IPC6 I)

.GAMMA.-

AMINOBUTYRIC ACID

6 [hp_X]

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:438 57-

0 149 -1

30 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n

Pro duc t

0 6 /15/20 16

BioActive Nutritional, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 9 /10 /20 13

Labeler -

BioActive Nutritional, Inc. (624980496)

Registrant -

Apotheca Company (844330915)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Apo the c a

Co mpany

8 44330 9 15

manufacture(438 57-0 149 ) , api manufacture(438 57-0 149 ) , label(438 57-0 149 ) , pack(438 57-

0 149 )

Revised: 6/2016

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