FDA.reportPublic FDA data

HYOSCYAMUS NIGER LEAF

Manufacturer
Uriel Pharmacy, Inc. | Uriel Pharmacy Inc.
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:29:02

Label at a glance#

ProductCrataegus comp.
Active ingredientHYOSCYAMUS NIGER LEAF, HAWTHORN LEAF WITH FLOWER, GOLD, PRIMULA VERIS FLOWER, ONOPORDUM ACANTHIUM FLOWER, SELENICEREUS GRANDIFLORUS STEM, BEEF HEART
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 age 2: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: 100gm contains: 2.5gm Onopordon (Cotton thistle) 1X, 2.5gm Primula (Cowslip) 1X; Hyoscyamus (Henbane) 3X; Crataegus (Hawthorn) 3X, Cactus (Queen of the night) 4X, Cor (Bovine heart) 6X, Aurum met. (Metallic gold) 15X

INACTIVE INGREDIENT SECTION


Inactive Ingredients: Distilled water, 30% Organic cane alcohol

Prepared using rhythmical processes.

OTC - PURPOSE SECTION

Use: Temporary relief of headache.

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.

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

Crataegus comp. LiquidCrataegus comp. Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-3274-3Crataegus comp.60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-3274CRATAEGUS COMP. LIQUID [URIEL PHARMACY, INC.]11 package rows20241123_27703028-96c0-2715-e063-6394a90aaacd.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-327448951-3274-3

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
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
HAWTHORN LEAF WITH FLOWER6OM09RPY36ACTIB
GOLD79Y1949PYOACTIB
WATER059QF0KO0RIACT
PRIMULA VERIS FLOWERW5BET37294ACTIB
ALCOHOL3K9958V90MIACT
ONOPORDUM ACANTHIUM FLOWERAP97AUF88EACTIB
SELENICEREUS GRANDIFLORUS STEM7114SV0MYKACTIB
BEEF HEARTP47W069U38ACTIB

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
27703028-96c1-2715-e063-6394a90aaacd27703028-96c0-2715-e063-6394a90aaacd2024-11-21WarningsExact identifier
spl id: 27703028-96c1-2715-e063-6394a90aaacd
spl set id: 27703028-96c0-2715-e063-6394a90aaacd

Reported adverse events (FAERS/openFDA)#

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