Pulsatilla

Manufacturer
Historical Remedies | Newton Laboratories, Inc.
Effective date
2025-10-07
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 02:37:20

Label at a glance#

ProductPulsatilla
Active ingredientANEMONE PULSATILLA
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for colds and nasal congestion.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults4 pellets; Children(4-12 years) 2 pellets; Dissolve under the tongue. Take every half hour as needed, or 4 times a day.

OTC - ACTIVE INGREDIENT SECTION

1% Pulsatilla 12x

OTC - PURPOSE SECTION

Formulated for cough and chest congestion.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic beet-derived sucrose; gluten-free, lactose-free, non-GMO

QUESTIONS SECTION

OTC - QUESTIONS SECTION

Distributed by Historical Remedies; 122 S Wabasha, Saint Paul, MN 55107; 800-676-6654

www.historicalremedies.com

WARNINGS SECTION

Warning: Consult a doctor if symptoms persist more than 3 days or worsen. If pregnant or nursing, ask a doctor before use. Keep out of reach of children. Do not use if tamper-evident band is missing or broken.

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57556-017-02Pulsatilla14 g in 1 BOTTLE, GLASSPELLET149

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
57556-01757556-017-02

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
ANEMONE PULSATILLAI76KB35JEVACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-10-31full-release2026-06-01 02:28:47

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
PulsatillaPULSATILLAHistorical Remediesc6790a91-d601-8c37-e053-2995a90a0a0c2025-10-07WarningsExact identifier
ndc (package): 57556-017-02
ndc (product): 57556-017
ndc11 (package): 57556001702
spl id: 40941606-17ac-43f2-e063-6394a90acbc2
spl set id: c6790a91-d601-8c37-e053-2995a90a0a0c

Reported adverse events (FAERS/openFDA)#

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