FDA.reportPublic FDA data

GABA

Manufacturer
Deseret Biologicals, Inc. | Apotheca Company
Effective date
2018-10-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:48:08

Label at a glance#

ProductGABA
Active ingredient.GAMMA.-AMINOBUTYRIC ACID
Label structure9 sections

Dosage and administration

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Gaba 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C.

HOMEOPATHIC INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of symptoms including anger, hostility, sleep difficulties and fatigue.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

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

Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, contact physician or Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

HOMEOPATHIC INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of symptoms including anger, hostility, sleep difficulties and fatigue.**

**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 25% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070   www.desbio.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DESBIO

NDC 43742-0695-1

HOMEOPATHIC

GABA

1 FL OZ (30 ml)

GABAGABA

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43742-069543742-0695-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
.GAMMA.-AMINOBUTYRIC ACID2ACZ6IPC6IACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2839ed69-cb05-4298-8e3e-5fe5f217714204e3aa4c-73dc-4e89-8736-d3443d2df9a52018-10-24WarningsExact identifier
spl id: 2839ed69-cb05-4298-8e3e-5fe5f2177142
spl set id: 04e3aa4c-73dc-4e89-8736-d3443d2df9a5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.