GABA 1519: Homeopathic Product Information

GABA 1519- .gamma.-aminobutyric acid liquid
Professional Complementary Health Formulas

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.

ACTIVE INGREDIENTS

Gamma-aminobutyric acid (GABA) 9X, 12X, 30X, 60X

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For the temporary relief of irritability, anxiousness, fatigue, or difficulty sleeping due to sensitivity to phenolic compounds found in foods or other products.*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

In case of overdose, get medical help or contact a poison control center right away.

Keep out of the reach of children.

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

20% ethanol, purified water.

LABEL

Est 1985

Professional Formulas

Complementary Health

GABA

Homeopathic Remedy

1 FL. OZ. (29.5 mL)

Label image

GABA 1519 gaba liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63083-1519 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 9 [hp_X] in 29.5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:63083-1519-1 29.5 mL in 1 BOTTLE, DROPPER None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/15/1984

Labeler — Professional Complementary Health Formulas (167339027)

Registrant — Natural Pharmaceutical Manufacturing LLC (015624923)

Establishment
Name	Address	ID/FEI	Operations
Natural Pharmaceutical Manufacturing LLC		015624923	manufacture (63083-1519)

Revised: 08/2019 Professional Complementary Health Formulas