FDA.reportPublic FDA data

Pulsatilla Tormentilla

Manufacturer
Uriel Pharmacy Inc.
Effective date
2019-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:11:32

Label at a glance#

ProductPulsatilla Tormentilla
Active ingredientPULSATILLA VULGARIS, POTENTILLA ERECTA ROOT, BEEF LIVER, HYDROXIDE ION
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 12: Consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Hepar (Bovine liver) 4X, Magnesium hydroxydatum (Magnesium hydroxide) 4X, Pulsatilla (Pasqueflower) 12X, Tormentilla (Bloodwort) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Organic sucrose

OTC - PURPOSE SECTION

Use: Temporarily relieves symptoms of premenstrual syndrome (PMS).

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pulsatilla Tormentilla PelletsPulsatilla Tormentilla Pellets

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48951-8360-22025-01-30C16284748780-12cef2736-6ebd-d83d-e063-dadaa90ab31fPulsatilla Tormentilla

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8360-2Pulsatilla Tormentilla1350 in 1 BOTTLE, GLASSPELLET13501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8360PULSATILLA TORMENTILLA PELLET [URIEL PHARMACY INC.]1Legacy NDC, 1 package rows20191102_964c9c6c-8e86-4699-e053-2a95a90a55e6.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48951-836048951-8360-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
PULSATILLA VULGARISI76KB35JEVACTIB
POTENTILLA ERECTA ROOTBI896CKT6BACTIB
BEEF LIVERW8N8R55022ACTIB
HYDROXIDE ION9159UV381PACTIB

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
964c9c6c-8e87-4699-e053-2a95a90a55e6964c9c6c-8e86-4699-e053-2a95a90a55e62019-11-01WarningsExact identifier
spl id: 964c9c6c-8e87-4699-e053-2a95a90a55e6
spl set id: 964c9c6c-8e86-4699-e053-2a95a90a55e6

Reported adverse events (FAERS/openFDA)#

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