FDA.reportPublic FDA data

PMS Relief

Manufacturer
BioEnergetics, Inc.
Effective date
2018-03-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:00:33

Label at a glance#

ProductPMS Relief
Active ingredientALETRIS FARINOSA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, PULSATILLA VULGARIS, SANGUINARIA CANADENSIS ROOT, SMILAX ORNATA ROOT, SEPIA OFFICINALIS JUICE, VERATRUM ALBUM ROOT
Label structure6 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Aletris farinosa 9x, Colocynthis 6x, Pulsatilla 6x, Sanguinaria canad 6x, Sarsaparilla 9x, Sepia 6x, Veratrum album 6x

Purpose

OTC - PURPOSE SECTION

Inactive ingredients:

INACTIVE INGREDIENT SECTION

alcohol 20%, purified water.

INDICATIONS & USAGE SECTION

For temporary relief of pre-menstrual discomfort including cramps, tender breasts, irritability, hot flushes.

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. 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 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

PMS ReliefPMS Relief

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57293-440557293-4405-2

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
ALETRIS FARINOSA ROOTO021JGR97XACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SMILAX ORNATA ROOT2H1576D5WGACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB

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
d350b07e-c0a4-a92b-e053-2995a90a4822499f5648-50db-4e07-aa8e-ba39939ba6932021-12-16WarningsExact identifier
spl set id: 499f5648-50db-4e07-aa8e-ba39939ba693

Reported adverse events (FAERS/openFDA)#

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