FDA.reportPublic FDA data

SEVENE USA - Menses Ease - Painful Periods

Manufacturer
SEVENE USA
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:00:54

Label at a glance#

ProductMenses Ease Painful Periods
Active ingredientLACHESIS MUTA WHOLE, STRYCHNOS IGNATII SEED, CIMICIFUGA RACEMOSA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP
Label structure11 sections

Storage and handling

Store at 59-77°F.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT HPUS

OTC - ACTIVE INGREDIENT SECTION

Cimicifuga Racemosa 9C - Colocynthis 9C - Ignatia Amara 9C - Lachesis Mutus 9C.

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to relieve symptoms of Difficult, Painful, Irregular Menses.

DOSAGE & ADMINISTRATION SECTION

Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INDICATIONS & USAGE SECTION

CIMICIFUGA RACEMOSA

Menstrual Discomfort & Cramps - Muscle Tension .*

COLOCYNTHIS

Cramping Abdominal Pain - Colic .*

IGNATIA AMARA

Sleeplessness, Nervousness, Hypersensitivity from Stress or Due to Emotional shock .*

LACHESIS MUTUS

Hot Flashes Associated with Menopause .*

WARNINGS SECTION

Consult a physician for use in children under 6 years of age.

Contact a doctor if symptoms persist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Store at 59-77°F.

OTC - DO NOT USE SECTION

Do not use if seal is broken or missing.

INACTIVE INGREDIENT SECTION

Organic Alcohol 20%

Purified Water

QUESTIONS?

OTC - QUESTIONS SECTION

Distributed by Sevene USA

East Troy, WI 53120 USA

1-855 - OLLOMED

QUESTIONS? info@ollois.com

www.ollois.com

MADE IN FRANCE.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. No guarantee to be effective. A homeopathic dilution may not to be susceptible to scientific measurement. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

étiquette 14étiquette 14étuis 14étuis 14

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
76472-701376472-7013-1, 76472-7013-2

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
LACHESIS MUTA WHOLE6Y582I290CACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
CIMICIFUGA RACEMOSA ROOTK73E24S6X9ACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
Menses Ease Painful PeriodsCIMICIFUGA RACEMOSA 9C, COLOCYNTHIS 9C, IGNATIA AMARA 9C, LACHESIS MUTUS 9CSEVENE USA5510b1d2-c979-d6f2-e063-6394a90a47672026-08-18WarningsExact identifier
ndc (package): 76472-7013-1
ndc (package): 76472-7013-2
ndc (product): 76472-7013
ndc11 (package): 76472701301
ndc11 (package): 76472701302
spl id: 594f4776-8dca-71af-e063-6294a90af993
spl set id: 5510b1d2-c979-d6f2-e063-6394a90a4767

Reported adverse events (FAERS/openFDA)#

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