FDA.reportPublic FDA data

Ignatia Passiflora Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:58:52

Label at a glance#

ProductIgnatia Passiflora Special Order
Active ingredientVALERIAN, ZINC VALERATE DIHYDRATE, STRYCHNOS IGNATII SEED, PASSIFLORA INCARNATA FLOWERING TOP
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions: FOR ORAL USE.

DOSAGE & ADMINISTRATION SECTION

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Valeriana e rad. 2X,
Passiflora ex herba 3X, Zincum
valerianicum 5X, Ignatia e sem. 6X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

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.

OTC - QUESTIONS SECTION

Questions? Call 866.642.2858
Made by Uriel, East Troy, WI 53120
www.urielpharmacy.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IgnatiaPassiflorasSOAmpulesIgnatiaPassiflorasSOAmpules

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-510248951-5102-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
VALERIANJWF5YAW3QWACTIB
ZINC VALERATE DIHYDRATEMN0RX54EQAACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB

Source Document#

Source XML · Source PDF

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
c4e7d42c-aefe-9461-e053-2a95a90af4fa6b9f13ae-2feb-50ad-e053-2991aa0a8a8d2021-06-16WarningsExact identifier
spl set id: 6b9f13ae-2feb-50ad-e053-2991aa0a8a8d

Reported adverse events (FAERS/openFDA)#

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