FDA.reportPublic FDA data

Scilla Crataegus

Manufacturer
Uriel Pharmacy Inc.
Effective date
2021-08-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:47

Label at a glance#

ProductScilla Crataegus
Active ingredientHAWTHORN LEAF WITH FLOWER, HYOSCYAMUS NIGER LEAF, ONOPORDUM ACANTHIUM FLOWER, DRIMIA MARITIMA BULB, ADONIS VERNALIS FLOWERING TOP, PRIMULA VERIS FLOWER, CONVALLARIA MAJALIS
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: Adonis (Spring Adonis) 3X, Crataegus (Hawthorn) 3X, Onopordon (Cotton thistle) 3X, Primula (Cowslip) 3X,
Convallaria (Lily of the valley) 4X, Hyoscyamus (Henbane) 4X, Scilla (Sea onion) 4X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

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. 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.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Scilla Crataegus PelletsScilla Crataegus Pellets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8382-2Scilla Crataegus1350 in 1 BOTTLE, GLASSPELLET13501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8382SCILLA CRATAEGUS PELLET [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20210803_c8989cce-551a-1de4-e053-2995a90a9976.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-838248951-8382-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HAWTHORN LEAF WITH FLOWER6OM09RPY36ACTIB
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
SUCROSEC151H8M554IACT
ONOPORDUM ACANTHIUM FLOWERAP97AUF88EACTIB
DRIMIA MARITIMA BULB3629601H5DACTIB
ADONIS VERNALIS FLOWERING TOP17A930VR0GACTIB
PRIMULA VERIS FLOWERW5BET37294ACTIB
CONVALLARIA MAJALISQHH4HVF5QEACTIB

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
c8989cce-551b-1de4-e053-2995a90a9976c8989cce-551a-1de4-e053-2995a90a99762021-08-02WarningsExact identifier
spl id: c8989cce-551b-1de4-e053-2995a90a9976
spl set id: c8989cce-551a-1de4-e053-2995a90a9976

Reported adverse events (FAERS/openFDA)#

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