FDA.reportPublic FDA data

Colds & Flu Drops

Manufacturer
BioEnergetics, Inc.
Effective date
2018-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:00:36

Label at a glance#

ProductColds and Flu
Active ingredientLACHESIS MUTA VENOM, PHOSPHORUS, PULSATILLA VULGARIS, ACONITUM NAPELLUS, ATROPA BELLADONNA, BRYONIA ALBA ROOT, DROSERA ROTUNDIFOLIA, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, GOLDENSEAL
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap 6x, Belladonna 12x, Bryonia alba 6x, Droserarotundofolia 6x, Eupatorium perf 9x, Gelsemium 12x, Hydrastis 9x, Lachesis 30x, Phosphorus 12x, Pulsatilla 6x

Purpose

OTC - PURPOSE SECTION

Inactive ingredients:

INACTIVE INGREDIENT SECTION

alcohol 20%, purified water.

INDICATIONS & USAGE SECTION

Natural relief for symptoms of the common cold and flu

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

Dosage:

DOSAGE & ADMINISTRATION SECTION

In general, 20 drops under the tongue 3 times daily. In acute conditions, 20 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

Cold & Flu DropsCold & Flu Drops

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57293-4410-22021-12-21C16284748780-1ab0b4bfd-9c65-d255-e053-dadaa90ae591Colds & Flu Drops
57293-4410-22020-07-22C16284748780-1ab0b4bfd-9c65-d255-e053-dadaa90ae591Colds & Flu Drops

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57293-441057293-4410-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACHESIS MUTA VENOMVSW71SS07IACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
DROSERA ROTUNDIFOLIAQR44N9XPJQACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
GOLDENSEALZW3Z11D0JVACTIB

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
d34fb6de-2f9f-76e2-e053-2a95a90a238799f87c54-bf3b-42f5-a065-efd7bd4fed192021-12-16WarningsExact identifier
spl set id: 99f87c54-bf3b-42f5-a065-efd7bd4fed19

Reported adverse events (FAERS/openFDA)#

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