FDA.reportPublic FDA data

Renes Betula

Manufacturer
Uriel Pharmacy Inc.
Effective date
2024-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:29:26

Label at a glance#

ProductRenes Betula
Active ingredientELYMUS REPENS TOP, ONONIS REPENS ROOT, PARSLEY, CAPSELLA BURSA-PASTORIS, ARCTOSTAPHYLOS UVA-URSI LEAF, SOLIDAGO VIRGAUREA FLOWERING TOP, BETULA PUBESCENS LEAF, EQUISETUM ARVENSE TOP, CYTISUS SCOPARIUS FLOWERING TOP, PORK KIDNEY, COPPER
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Dissolve pellets under the tongue 3-4 times daily. Ages 12 and older: 10 pellets. Ages 2-11: 5 pellets. Under age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Agropyrum e. rad. (Couch grass) 2X, Ononidis (Moth) 2X, Petroselinium (Parsley herb) 2X, Petroselinium (Parsley root) 2X, Solidago (Goldenrod) 2X, Capsella bursa pastoris (Shepherd’s purse) 2X, Uva ursi (Bearberry) 2X, Betula (Silver birch leaves) 3X, Equisetum (Common horsetail) 3X, Sarothamnus (Broom) 3X, Renes (Bovine kidneys) 4X, Cuprum met. (Copper) 8X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Sucrose

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Use: Temporary relief of urinary discomfort.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858 Uriel, East Troy, WI 53120 shopuriel.com Lot:

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Contains sugar. Diabetics and persons intolerant of sucrose (sugar): Consult a doctor before use. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Renes Betula PelletsRenes Betula Pellets

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8426-2Renes Betula1350 in 1 BOTTLE, GLASSPELLET13501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8426RENES BETULA PELLET [URIEL PHARMACY INC.]11 package rows20241212_28efb40a-1efb-5de1-e063-6394a90a21e6.zip

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
48951-842648951-8426-2

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
SUCROSEC151H8M554IACT
ELYMUS REPENS TOP8K1MK5E1FYACTIB
ONONIS REPENS ROOTW06YCM9T44ACTIB
PARSLEY58FMD0Q0EVACTIB
CAPSELLA BURSA-PASTORISW0X9457M59ACTIB
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
BETULA PUBESCENS LEAF84SOH0O3OOACTIB
EQUISETUM ARVENSE TOP1DP6Y6B65ZACTIB
CYTISUS SCOPARIUS FLOWERING TOPXZC6H8R666ACTIB
PORK KIDNEYX7BCI5P86HACTIB
COPPER789U1901C5ACTIB

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
28efbc1f-bb52-7947-e063-6294a90a592728efb40a-1efb-5de1-e063-6394a90a21e62024-12-10WarningsExact identifier
spl id: 28efbc1f-bb52-7947-e063-6294a90a5927
spl set id: 28efb40a-1efb-5de1-e063-6394a90a21e6

Reported adverse events (FAERS/openFDA)#

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