FDA.reportPublic FDA data

ACONITUM NAPELLUS

Manufacturer
SEVENE USA
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:25:45

Label at a glance#

ProductACONITUM NAPELLUS 200ck
Active ingredientACONITUM NAPELLUS
Label structure12 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

ACONITUM NAPELLUS 200CK**

**C, K, CK, AND X ARE HOMEOPATHIC DILUTIONS.

TRADITIONALLY USED FOR

OTC - PURPOSE SECTION

Temporarily reducing sudden fever & cough associated with cold or flu*

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 INGREDIENTS

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 HOMEOPATHIC DILUTION MAY NOT BE SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-3000-1ACONITUM NAPELLUS200ck80 in 1 CYLINDERPELLET803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-3000ACONITUM NAPELLUS 200CK (ACONITUM NAPELLUS) PELLET [SEVENE USA]3Current NDC, Legacy NDC, 1 package rows20240119_c89907e7-fa1c-9b1e-e053-2a95a90aac62.zip

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
76472-300076472-3000-1

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
ACONITUM NAPELLUSU0NQ8555JDACTIB

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
ACONITUM NAPELLUS 200ckACONITUM NAPELLUSSEVENE USAc89907e7-fa1c-9b1e-e053-2a95a90aac622024-01-18WarningsExact identifier
ndc (package): 76472-3000-1
ndc (product): 76472-3000
ndc11 (package): 76472300001
spl id: 0f3fe746-1484-0694-e063-6294a90a1583
spl set id: c89907e7-fa1c-9b1e-e053-2a95a90aac62

Reported adverse events (FAERS/openFDA)#

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