FDA.reportPublic FDA data

Pulsatilla

Manufacturer
SEVENE USA
Effective date
2022-06-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:59:31

Label at a glance#

ProductPulsatilla
Active ingredientPULSATILLA VULGARIS
Label structure13 sections

Dosage and administration

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF HPUS Pulsatilla 6c.

TRADITIONALLY USE FOR:

OTC - PURPOSE SECTION

Ocular or nasal yellow discharge associated with cold*

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

USE:

INDICATIONS & USAGE SECTION

Condition listed above or as directed by a physician.

WARNINGS:

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT:

INACTIVE INGREDIENT SECTION

Sucrose.

QUESTIONS?

OTC - QUESTIONS SECTION

INFO@OLLOIS.COM * WWW.OLLOIS.COM * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIS DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

USE:

RECENT MAJOR CHANGES SECTION

Condition listed above or as directed by a physician.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PULSATILLA 6CPULSATILLA 6C

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-403076472-4030-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
PULSATILLA VULGARISI76KB35JEVACTIB

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
05414a66-8432-8f96-e063-6394a90a81c5e11ea06f-3bf6-c219-e053-2995a90a18222023-09-13WarningsExact identifier
spl set id: e11ea06f-3bf6-c219-e053-2995a90a1822

Reported adverse events (FAERS/openFDA)#

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