RxNorm Names

Not yet provided

GABA liquid
[BioActive Nutritional, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=4fe29a89-c4d6-446c-b5f7-692762c58614

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		unapproved homeopathic

NOTE: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 Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

ACTIVE INGREDIENTS

Gaba 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 cool, dry place.

DIRECTIONS

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

INACTIVE INGREDIENTS

Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS AND USAGE

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

QUESTIONS

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

BioActive Homeopathic

GABA

1 FL OZ (30 ml)

Gaba

GABA
gaba liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0123
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.GAMMA.-AMINOBUTYRIC ACID (.GAMMA.-AMINOBUTYRIC ACID)	.GAMMA.-AMINOBUTYRIC ACID	6 [hp_X] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
ALCOHOL

Packaging
#	Item Code	Package Description
1	NDC:43857-0123-1	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/08/2013

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0123)

Revised: 01/2013

Document Id: e797e8aa-20f4-4b07-9bc6-ac59afd9baa6

Set id: 4fe29a89-c4d6-446c-b5f7-692762c58614

Version: 1

Effective Time: 20130108