FDA.reportPublic FDA data

SEVENE USA - Urinary comfort - Urinary Discomfort

Manufacturer
SEVENE USA
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:00:55

Label at a glance#

ProductUrinary Comfort Urinary discomfort
Active ingredientBERBERIS VULGARIS ROOT BARK, SOLIDAGO VIRGAUREA FLOWERING TOP, FILIPENDULA ULMARIA ROOT
Label structure11 sections

Dosage and administration

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.

Storage and handling

Store at 59-77°F.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT HPUS

OTC - ACTIVE INGREDIENT SECTION

Berberis Vulgaris 3C – Solidago Virgaurea 3C - Spiraea Ulmaria 3C.

TRADITIONALLY USED FOR

OTC - PURPOSE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to relieve symptoms of urinary discomfort:

- Burning, Frequent, Difficult, Scanty Urination

- Cloudy Urine

- Urinary Tract Irritation

DIRECTIONS

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

BERBERIS VULGARIS

Radiating urinary pain - Skin rash with round, red patches and thin flakes .*

SOLIDAGO VIRGAUREA

Nephritis - Cystitis - Urinary Retention - Kidney Pain .*

SPIRAEA ULMARIA

Urinary Tract Irritation - Prostate-related issues .*

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 12étiquette 12étuis 12étuis 12

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-701176472-7011-1, 76472-7011-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
FILIPENDULA ULMARIA ROOT997724QNDSACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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
Urinary Comfort Urinary discomfortBERBERIS VULGARIS 3C, SOLIDAGO VIRGAUREA 3C, SPIRAEA ULMARIA 3CSEVENE USA5501026c-9edb-8f89-e063-6394a90a7d5c2026-08-18WarningsExact identifier
ndc (package): 76472-7011-2
ndc (package): 76472-7011-1
ndc (product): 76472-7011
ndc11 (package): 76472701101
ndc11 (package): 76472701102
spl id: 594f4c4f-f5d5-7852-e063-6294a90a61f2
spl set id: 5501026c-9edb-8f89-e063-6394a90a7d5c

Reported adverse events (FAERS/openFDA)#

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