HELLEBORUS NIGER

Manufacturer: Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Effective date: 2020-03-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:12:35

Label at a glance#

ProductHELLEBORUS NIGER

Active ingredientHELLEBORUS NIGER ROOT

Label structure9 sections

Indications and uses

Depression

Storage and handling

Store in a cool dark place

Contacts and useful links#

Websitewww.rxhomeo.com

www.Rxhomeo.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HELLEBORUS NIGER HPUS 3X and higher

USES

OTC - PURPOSE SECTION

Depression

INDICATIONS

INDICATIONS & USAGE SECTION

Condition listed above or as directed by the physician

DOSAGE

DOSAGE & ADMINISTRATION SECTION

Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.

WARNINGS

WARNINGS SECTION

This product is to be used for self-limiting conditions

OTC - STOP USE SECTION

If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children

OTC - DO NOT USE SECTION

Do not use if capseal is broken or missing.

Close the cap tightly after use.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sucrose

STORAGE

STORAGE AND HANDLING SECTION

Store in a cool dark place

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

www.rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
15631-0221-0	2022-01-28	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-1	2022-01-28	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-2	2022-01-28	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-3	2022-01-28	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-4	2022-01-28	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-5	2022-01-28	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-0	2020-03-20	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-1	2020-03-20	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-2	2020-03-20	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-3	2020-03-20	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-4	2020-03-20	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-5	2020-03-20	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-0	2020-01-31	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-1	2020-01-31	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-2	2020-01-31	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-3	2020-01-31	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-4	2020-01-31	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e
15631-0221-5	2020-01-31	C162847	48780-1	9d75b9d0-4e31-f424-e053-dadaa90a57ce	a21b3d98-2978-42cb-b264-65758561d85e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
15631-0221-0	HELLEBORUS NIGER	100 in 1 PACKAGE	PELLET	100	2
15631-0221-1	HELLEBORUS NIGER	200 in 1 PACKAGE	PELLET	200	2
15631-0221-2	HELLEBORUS NIGER	400 in 1 PACKAGE	PELLET	400	2
15631-0221-3	HELLEBORUS NIGER	750 in 1 PACKAGE	PELLET	750	2
15631-0221-4	HELLEBORUS NIGER	2500 in 1 PACKAGE	PELLET	2500	2
15631-0221-5	HELLEBORUS NIGER	12500 in 1 PACKAGE	PELLET	12500	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
15631-0221	HELLEBORUS NIGER PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]	2	Legacy NDC, 6 package rows	20200320_a21b3d98-2978-42cb-b264-65758561d85e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HELLEBORUS NIGER ROOT	ACTIVE INGREDIENT	608DGJ6815	1
HELLEBORUS NIGER ROOT	ACTIVE MOIETY	608DGJ6815	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

HELLEBORUS NIGER
SUCROSE
HELLEBORUS NIGER ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
15631-0221	15631-0221-0, 15631-0221-1, 15631-0221-2, 15631-0221-3, 15631-0221-4, 15631-0221-5

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
Name	UNII	Kind
SUCROSE	C151H8M554	IACT
HELLEBORUS NIGER ROOT	608DGJ6815	ACTIB

Source Document#

Source XML

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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	119.12 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		18790 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SUSPENSION / ORAL		31885 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CONCENTRATE / ORAL		4800 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION / ORAL		48209 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		1 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE / ORAL		3568 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	900 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LOZENGE / TRANSMUCOSAL		1255 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / ORAL		70000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, DELAYED RELEASE / ORAL	295.33 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION/ DROPS / ORAL		3750 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION / SUBCUTANEOUS	47.75 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		2000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SOLUTION / RECTAL	35.42 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	SUSPENSION, EXTENDED RELEASE / ORAL		5400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, EXTENDED RELEASE / ORAL	284.54 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	ELIXIR / ORAL		18000 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED PELLETS / ORAL	59.8 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	DROPS / ORAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	POWDER, FOR SUSPENSION / ORAL		40017 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / BUCCAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION / INTRAVENOUS		1950 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTABLE, LIPOSOMAL / INTRAVENOUS		7560 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TROCHE / BUCCAL	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		308 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, EMULSION / INTRAVENOUS		970 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a14729bb-05ca-9209-e053-2a95a90adea1			a21b3d98-2978-42cb-b264-65758561d85e	2020-03-20	Warnings	Exact identifier spl id: a14729bb-05ca-9209-e053-2a95a90adea1 spl set id: a21b3d98-2978-42cb-b264-65758561d85e

Reported adverse events (FAERS/openFDA)#

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