FDA.reportPublic FDA data

Pulsatilla Tormentilla

Manufacturer
Uriel Pharmacy Inc.
Effective date
2018-04-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:09:30

Label at a glance#

ProductPulsatilla Tormentilla
Active ingredientMAMMAL LIVER, MAGNESIUM HYDROXIDE, PULSATILLA VULGARIS, POTENTILLA ERECTA ROOT
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 Ingredients: Hepar (Bovine liver) 4X, Magnesium hydroxydatum (Magnesium hydroxide) 4X, Pulsatilla (Pasqueflower) 12X, Tormentilla (Bloodwort) 30X

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled water, Propolis

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. 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

PulsatillaTormentillaLiquidPulsatillaTormentillaLiquid

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8099-3Pulsatilla Tormentilla60 mL in 1 BOTTLE, DROPPERLIQUID604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8099PULSATILLA TORMENTILLA LIQUID [URIEL PHARMACY INC.]4Legacy NDC, 1 package rows20180430_e4c5306d-43c5-4c2b-8008-95db8fe0d1df.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MAGNESIUM HYDROXIDEACTIVE INGREDIENTNBZ3QY004S1
MAMMAL LIVERACTIVE INGREDIENTD0846624BI1
POTENTILLA ERECTA ROOTACTIVE INGREDIENTBI896CKT6B1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
MAMMAL LIVERACTIVE MOIETYD0846624BI1
POTENTILLA ERECTA ROOTACTIVE MOIETYBI896CKT6B1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
PROPOLIS WAXINACTIVE INGREDIENT6Y8XYV2NOF1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
48951-809948951-8099-3

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
WATER059QF0KO0RIACT
PROPOLIS WAX6Y8XYV2NOFIACT
MAMMAL LIVERD0846624BIACTIB
MAGNESIUM HYDROXIDENBZ3QY004SACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
POTENTILLA ERECTA ROOTBI896CKT6BACTIB

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
6b1422ef-3da0-6227-e053-2a91aa0ac046e4c5306d-43c5-4c2b-8008-95db8fe0d1df2018-04-30WarningsExact identifier
spl id: 6b1422ef-3da0-6227-e053-2a91aa0ac046
spl set id: e4c5306d-43c5-4c2b-8008-95db8fe0d1df

Reported adverse events (FAERS/openFDA)#

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