Belladonna

Manufacturer
SEVENE USA
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:31:59

Label at a glance#

ProductBelladonna 200ck
Active ingredientATROPA BELLADONNA
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 Belladonna 200ck **C, K, CK, AND X ARE HOMEOPATHIC DILUTIONS

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

Temporarily reducing fever with perspiration* - Headache* - Inflammation*

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 HOMEOPATHIC 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

BELLADONNA 200CKBELLADONNA 200CKBELLADONNA 200CKBELLADONNA 200CKCOMMONCOMMON

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-3005-1Belladonna200ck80 in 1 CYLINDERPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-3005BELLADONNA 200CK (ATROPA BELLADONNA) PELLET [SEVENE USA]4Current NDC, Legacy NDC, 1 package rows20250213_c8d30961-fc0d-c8f1-e053-2995a90a2a8f.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
76472-300576472-3005-1

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
ATROPA BELLADONNAWQZ3G9PF0HACTIB

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
Belladonna 200ckATROPA BELLADONNASEVENE USAc8d30961-fc0d-c8f1-e053-2995a90a2a8f2025-02-11WarningsExact identifier
ndc (package): 76472-3005-1
ndc (product): 76472-3005
ndc11 (package): 76472300501
spl id: 2ddc212b-814d-d790-e063-6394a90aa58e
spl set id: c8d30961-fc0d-c8f1-e053-2995a90a2a8f

Reported adverse events (FAERS/openFDA)#

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