FDA.reportPublic FDA data

Pulsatilla

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:14:00

Label at a glance#

ProductPulsatilla
Active ingredientPULSATILLA VULGARIS
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Yellow discharges; Runny nose; Colds; Menses delayed; Changeable moods; Changeable symptoms.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Pulsatilla 15x, 10x, 200c, 30c.

OTC - PURPOSE SECTION

Yellow discharges; Runny nose; Colds; Menses delayed; Changeable moods; Changeable symptoms.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 1.800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS:Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-6440-12023-01-30C16284748780-1f386c64a-0825-0266-e053-dadaa90a7c1aPulsatilla 6440L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-6440-1Pulsatilla30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-6440PULSATILLA LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 1 package rows20201218_19a1c484-a54f-bc1b-aa97-a5bdc72781aa.zip

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
55714-644055714-6440-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
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
b6acbc78-7cb5-20fb-e053-2a95a90af7c019a1c484-a54f-bc1b-aa97-a5bdc72781aa2020-12-17WarningsExact identifier
spl id: b6acbc78-7cb5-20fb-e053-2a95a90af7c0
spl set id: 19a1c484-a54f-bc1b-aa97-a5bdc72781aa

Reported adverse events (FAERS/openFDA)#

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