FDA.reportPublic FDA data

BioE Headache

Manufacturer
BioEnergetics, Inc.
Effective date
2018-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:00:35

Label at a glance#

ProductBioE Headache
Active ingredientARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTAEA CIMICIFUGA ROOT, TUBOCURARINE CHLORIDE, CYCLAMEN PURPURASCENS TUBER, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, IRIS VERSICOLOR ROOT, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ANEMONE PULSATILLA, TOXICODENDRON RADICANS LEAF, SANGUINARIA CANADENSIS ROOT, CLAVICEPS PURPUREA SCLEROTIUM, SPIGELIA MARILANDICA ROOT
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Arsenicum alb 12x, Belladonna 12x, Cimicifuga 6x, Curare 12x, Cyclamen 6x, Gelsemium 6x, Glonoin 9x, Iris versicolor 6x, Mag phos 12, Pulsatilla 6x, Rhus tox 6x, Sanguinaria 6x, Secale corn 6x, Spigelia 6x

Purpose

OTC - PURPOSE SECTION

Inactive ingredients:

INACTIVE INGREDIENT SECTION

alcohol 20%, purified water.

INDICATIONS & USAGE SECTION

For temporary relief of various types of headaches including migraine.

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

BioE HeadacheBioE Headache

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57293-4422-22021-12-21C16284748780-1ab0b4bfd-9bed-d255-e053-dadaa90ae591BioE Headache
57293-4422-22020-07-22C16284748780-1ab0b4bfd-9bed-d255-e053-dadaa90ae591BioE Headache

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57293-442257293-4422-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
ACTAEA CIMICIFUGA ROOT65J267BAZTACTIB
TUBOCURARINE CHLORIDE900961Z8VRACTIB
CYCLAMEN PURPURASCENS TUBERG728143D8QACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
NITROGLYCERING59M7S0WS3ACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
TOXICODENDRON RADICANS LEAFCDH3461U7LACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
SPIGELIA MARILANDICA ROOT467D26HS0BACTIB

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
d34fce54-d275-6e6b-e053-2995a90a86a071c12fac-2677-4a37-807a-8eec95f7b6502021-12-16WarningsExact identifier
spl set id: 71c12fac-2677-4a37-807a-8eec95f7b650