FDA.reportPublic FDA data

Aquilinum Taraxacum Ampules

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-05-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:09:34

Label at a glance#

ProductAquilinum Taraxacum Ampules
Active ingredientDRYOPTERIS FILIX-MAS ROOT, PTERIDIUM AQUILINUM WHOLE, CHELIDONIUM MAJUS, TARAXACUM PALUSTRE ROOT, SALIX ALBA FLOWER, SOLIDAGO VIRGAUREA FLOWERING TOP, SALIX PURPUREA BARK, WILLOW BARK, ASPLENIUM SCOLOPENDRIUM 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: Chelidonium (Greater celandine) 5X, Filix (Male fern) 5X, Pteridium (Eagle fern) 5X, Salix purpurea (Purple willow) 5X, Salix vitellina (Golden willow) 5X, Salix viminalis (Osier willow) 5X, Scolopendrium (Hart’s tongue) 5X, Solidago (Goldenrod) 5X, Taraxacum (Dandelion) 5X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Salt

OTC - PURPOSE SECTION

Use: Temporary relief of digestive upset.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AquilinumTaraxacumAmpulesAquilinumTaraxacumAmpules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-1285-1Aquilinum Taraxacum Ampules10 in 1 BOXLIQUID102
48951-1285-1Aquilinum Taraxacum Ampules1 mL in 1 AMPULELIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-1285AQUILINUM TARAXACUM AMPULES LIQUID [URIEL PHARMACY INC.]2Legacy NDC, 2 package rows20180503_6b3bec12-e6c0-ad71-e053-2a91aa0a2225.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-128548951-1285-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
DRYOPTERIS FILIX-MAS ROOTC0ZK0RRF5XACTIB
PTERIDIUM AQUILINUM WHOLE05T3M06HCMACTIB
WATER059QF0KO0RIACT
CHELIDONIUM MAJUS7E889U5RNNACTIB
TARAXACUM PALUSTRE ROOTGCZ4W7077CACTIB
SALIX ALBA FLOWER905Y746BSWACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
SALIX PURPUREA BARK287VJO13M9ACTIB
WILLOW BARKS883J9JDYXACTIB
ASPLENIUM SCOLOPENDRIUM TOPHJA3YWQ7HLACTIB

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
6b3ec25a-65b0-de80-e053-2991aa0aa70d6b3bec12-e6c0-ad71-e053-2a91aa0a22252018-05-02WarningsExact identifier
spl id: 6b3ec25a-65b0-de80-e053-2991aa0aa70d
spl set id: 6b3bec12-e6c0-ad71-e053-2a91aa0a2225

Reported adverse events (FAERS/openFDA)#

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