Passiflora ex herba 1 Special Order

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-04-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:09:28

Label at a glance#

ProductPassiflora ex herba 1 Special Order
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP
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 Ingredient: Passiflora ex herba 2X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, Propolis

OTC - PURPOSE SECTION

Use: Temporary relief of sleeplessness.

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.

REFRIGERATE AFTER OPENING.
BEST WHEN USED WITHIN 30 DAYS OF OPENING.

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PassifloraExHerba1SOLiquidPassifloraExHerba1SOLiquid

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-8013-32026-01-29C16284748780-149896155-a959-586f-e063-e6dba90add90Passiflora ex herba 1 Special Order

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8013-3Passiflora ex herba 1 Special Order60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8013PASSIFLORA EX HERBA 1 SPECIAL ORDER LIQUID [URIEL PHARMACY INC.]2Legacy NDC, 1 package rows20180428_1022e764-5b37-4653-982d-eab8a6f0f0a5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O1
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O1
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
48951-801348951-8013-3

Ingredients#

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

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

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
6ad9ecf6-9627-c638-e053-2a91aa0a1f2b1022e764-5b37-4653-982d-eab8a6f0f0a52018-04-27WarningsExact identifier
spl id: 6ad9ecf6-9627-c638-e053-2a91aa0a1f2b
spl set id: 1022e764-5b37-4653-982d-eab8a6f0f0a5

Reported adverse events (FAERS/openFDA)#

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