FDA.reportPublic FDA data

Prunus spinosa et summ. 30

Manufacturer
Uriel Pharmacy, Inc
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:38:06

Label at a glance#

ProductPrunus spinosa et summ. 30
Active ingredientSLOE
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE ONLY.

DOSAGE & ADMINISTRATION SECTION

Take 3-4 times daily. Ages 12 and older: 10 drops.
Ages 2-11: 5 drops. Under 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: 100 gm contains: 30gm Prunus spinosa et summ. (Blackthorn) 1X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, 30% Organic cane alcohol

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Use: Temporary relief of fatigue.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

WARNINGS SECTION

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. 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.

SHAKE WELL BEFORE USE.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
shopuriel.com Lot:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prunus spinosa et summ. 30 LiquidPrunus spinosa et summ. 30 Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8442-3Prunus spinosa et summ. 3060 mL in 1 BOTTLE, DROPPERLIQUID601

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-844248951-8442-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SLOE3MLB4858X7ACTIB
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
Prunus spinosa et summ. 30PRUNUS SPINOSA ET SUMM. 30Uriel Pharmacy, Inc4d7a43b0-f914-e35b-e063-6294a90a0ed32026-03-20WarningsExact identifier
ndc (package): 48951-8442-3
ndc (product): 48951-8442
ndc11 (package): 48951844203
spl id: 4d7a43b0-f915-e35b-e063-6294a90a0ed3
spl set id: 4d7a43b0-f914-e35b-e063-6294a90a0ed3

Reported adverse events (FAERS/openFDA)#

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