ACONITUM NAPELLUS

Manufacturer
SEVENE USA
Effective date
2024-01-23
Label type
HUMAN OTC DRUG LABEL
Version
39
Source
full-release
Hydrated at
2026-06-01 02:25:51

Label at a glance#

ProductACONITUM NAPELLUS
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

HOMEOPATHIC DILUTION OF HPUS ACONITUM NAPELLUS 30c

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

ACONITUM_NAPELLUS_30c_P1ACONITUM_NAPELLUS_30c_P1

ACONITUM_NAPELLUS_30c_P2ACONITUM_NAPELLUS_30c_P2

0-LBL_pg30-LBL_pg3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-1123-1ACONITUM NAPELLUS80 in 1 CYLINDERPELLET8039

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-1123ACONITUM NAPELLUS PELLET [SEVENE USA]39Current NDC, Legacy NDC, 1 package rows20240127_62663741-0b6c-4dce-83ec-bb7ded059672.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD15
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD15
SucroseINACTIVE INGREDIENTC151H8M55415

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-112376472-1123-1

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 · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii+route
2 equally ranked IID candidates
SucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii+route
2 equally ranked IID candidates

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 NAPELLUSACONITUM NAPELLUSSEVENE USA62663741-0b6c-4dce-83ec-bb7ded0596722024-01-23WarningsExact identifier
ndc (package): 76472-1123-1
ndc (product): 76472-1123
ndc11 (package): 76472112301
spl id: 0fa34f11-e904-3295-e063-6294a90a1d93
spl set id: 62663741-0b6c-4dce-83ec-bb7ded059672

Reported adverse events (FAERS/openFDA)#

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