FDA.reportPublic FDA data

Insomnia

Manufacturer
BioEnergetics, Inc.
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:50:30

Label at a glance#

ProductInsomnia
Active ingredientAVENA SATIVA FLOWERING TOP, ATROPA BELLADONNA, BELLIS PERENNIS, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, HYOSCYAMUS NIGER, SCUTELLARIA LATERIFLORA
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avena sativa 6x,

Belladonna 12x,

Bellis perennis 6x,

Chamomilla 6x,

Coffea Cruda 6x,

Hyoscyamus nig 6x,

Scutellaria lateriflora 12x

Purpose

OTC - PURPOSE SECTION

Inactive ingredients:

INACTIVE INGREDIENT SECTION

alcohol 20%, purified water.

INDICATIONS & USAGE SECTION

Recommended for light, restless sleep, and insomnia.

These uses are based on traditional homeopathic practice. They have not been evauated by the FDA.

Dosage:

DOSAGE & ADMINISTRATION SECTION

In general, 10 drops under the tongue 3 times daily. In acute conditions, 10 drops every 15 minutes.  Children, one half the above dosage. For children 2 years and under, and for people nursing a baby or pregnant, seek the advice of a health professional before use.

WARNINGS SECTION

DO NOT USE

OTC - DO NOT USE SECTION

IF BioE IMPRINTED SEAL ON NECK IS BROKEN

OTC - STOP USE SECTION

If symptoms worsen or persist for more than 7 days, consult a physician.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Insomnia ReliefInsomnia Relief

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57293-440457293-4404-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BELLIS PERENNIS2HU33I03UYACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
SCUTELLARIA LATERIFLORA7BP4DH5PDCACTIB

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
d3504ba6-511c-6cb0-e053-2995a90af7c196b54b36-77c5-4d1b-b3e5-b7867af20cc22021-12-16WarningsExact identifier
spl set id: 96b54b36-77c5-4d1b-b3e5-b7867af20cc2

Reported adverse events (FAERS/openFDA)#

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