Helleborus Niger

Manufacturer
True Botanica, LLC
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:18:57

Label at a glance#

ProductHelleborus Niger
Active ingredientHELLEBORUS NIGER ROOT
Label structure11 sections

Dosage and administration

Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Helleborus Niger 6X, HPUS

The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Homeopathic support for the mind (low mental focus, dark moods, etc.) and the body (healthy prostate function, immune system, more). May also be used for standard homeopathic indications or as directed by your physician.

Use:

INDICATIONS & USAGE SECTION

Homeopathic support for the mind (low mental focus, dark moods, etc.) and the body (healthy prostate function, immune system, more). May also be used for standard homeopathic indications or as directed by your physician.

Warnings:

WARNINGS SECTION

Consult your health care provider if symptoms persist more than 5 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - DO NOT USE SECTION

TAMPER EVIDENT: Do not use if safety seal is broken before first use.

Directions for Use:

DOSAGE & ADMINISTRATION SECTION

Place globules under tongue for 30 seconds. Adults~3-5 globules 3 times a day. Children 2-12 years ~ 1-3 globules 3 times a day. Under 2 years, consult your doctor. Use until symptoms are relieved or as directed by your health care provider.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Sucrose

OTC - QUESTIONS SECTION

Developed and Made by

True Botanica, LLC

1005 Richards Rd., Suite D

Hartland, WI 53029

800-315-8783

www.truebotanica.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Helleborus Niger 6XHelleborus Niger 6X

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53645-2070-32024-01-30C16284748780-1ba0f9c33-3f54-a910-e053-dadaa90a0b85Helleborus Niger 6X
53645-2070-32021-01-31C16284748780-1ba0f9c33-3f54-a910-e053-dadaa90a0b85Helleborus Niger 6X
53645-2070-32021-01-29C16284748780-1ba0f9c33-3f54-a910-e053-dadaa90a0b85Helleborus Niger 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-2070-3Helleborus Niger23 g in 1 BOTTLEGLOBULE234

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-2070HELLEBORUS NIGER GLOBULE [TRUE BOTANICA, LLC]4Legacy NDC, 1 package rows20221220_61997e4b-3f8a-26f8-e053-2a91aa0aec6f.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
53645-207053645-2070-3

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
HELLEBORUS NIGER ROOT608DGJ6815ACTIB

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
f03275ed-974f-0492-e053-2995a90aa54d61997e4b-3f8a-26f8-e053-2a91aa0aec6f2022-12-19WarningsExact identifier
spl id: f03275ed-974f-0492-e053-2995a90aa54d
spl set id: 61997e4b-3f8a-26f8-e053-2a91aa0aec6f

Reported adverse events (FAERS/openFDA)#

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