FDA.reportPublic FDA data

BioE Migraine

Manufacturer
BioEnergetics, Inc.
Effective date
2018-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:00:32

Label at a glance#

ProductBioE Migraine
Active ingredientGOLDENSEAL, LARICIFOMES OFFICINALIS FRUITING BODY, TANACETUM VULGARE TOP, TARAXACUM PALUSTRE ROOT
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydrastis can. 9x

Polyporus off. 6x

Tanacetum 6x

Taraxacum 6x

OTC - PURPOSE SECTION

Inactive ingredients:

INACTIVE INGREDIENT SECTION

alcohol 20%, purified water.

INDICATIONS & USAGE SECTION

Recommended for relief of migraine headache symptoms.

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

Dosage:

DOSAGE & ADMINISTRATION SECTION

At onset of symptoms, 10 drops under the tongue every 15 minutes for the first hour, then once an hour. Discontinue when symptoms have cleared. Children, one half the above dosage. For children 2 years and under, and if 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 sysmptoms 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

BioE MigraineBioE Migraine

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57293-442657293-4426-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
GOLDENSEALZW3Z11D0JVACTIB
LARICIFOMES OFFICINALIS FRUITING BODY7IFM8431X3ACTIB
TANACETUM VULGARE TOPD52957JQ8MACTIB
TARAXACUM PALUSTRE ROOTGCZ4W7077CACTIB

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
d34f9964-c3be-7ed1-e053-2a95a90a9ef70e0822bb-0919-4e61-bc38-37a2509ca5a62021-12-16WarningsExact identifier
spl set id: 0e0822bb-0919-4e61-bc38-37a2509ca5a6

Reported adverse events (FAERS/openFDA)#

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